CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report

Np Fem Lt Sz0 Natural-kne Np Fem Rt Sz0 Natural-kne Np Fem recalled

Zimmer Biomet is recalling Np Fem Lt Sz0 Natural-kne Np Fem Rt Sz0 Natural-kne Np Fem Lt Sz2 Natural-kne Np Fem Rt, distributed nationwide in the US. The recall was initiated on 29 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes6307-00-008 62125578 6307-00-020 61975784 6307-00-020 62098206 6307-00-030 11004845 6307-00-030 62142198 6307-00-009 62107229 6307-00-021 11004878 6307-00-021 62160819 6307-00-021 62155319 6307-00-021 62162357 6307-00-021 62164084 6307-00-021 62176798 6307-00-021 62174770 6307-00-021 62173770 6307-00-021 62177132 6307-00-021 62172373 6307-00-021 62178184 6307-00-021 62178731 6307-00-021 62183228 6307-00-021 62180483 6307-00-021 62185696 6307-00-021 62181538 6307-00-021 62188142 6307-00-021 11007719 6307-00-021 62189950 6307-00-021 62193587 6307-00-021 62190389 6307-00-021 62192798 6307-00-021 62196210 6307-00-021 62194526 6307-00-021 11007656 6307-00-021 62200791 6307-00-021 62203902 6307-00-021 62206609 6307-00-021 11007666 6307-00-021 62191204 6307-00-021 11007831 6307-00-021 11007677 6307-00-021 11007922 6307-00-021 11007925 6307-00-021 11007944 6307-00-021 62210574 6307-00-021 62208953 6307-00-021 62210107 6307-00-021 62207438 6307-00-021 11008018

Quantity recalled13,227 in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1033-2018
FDA event ID: 78706
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 29 Nov 2017
FDA classified: 14 Mar 2018
Reported: 21 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

29 Nov 2017	Recall initiated by company
14 Mar 2018	Classified by FDA	+105 days
21 Mar 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating

Where it was distributed

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

6307-00-008 62125578 6307-00-020 61975784 6307-00-020 62098206 6307-00-030 11004845 6307-00-030 62142198 6307-00-009 62107229 6307-00-021 11004878 6307-00-021 62160819 6307-00-021 62155319 6307-00-021 62162357 6307-00-021 62164084 6307-00-021 62176798 6307-00-021 62174770 6307-00-021 62173770 6307-00-021 62177132 6307-00-021 62172373 6307-00-021 62178184 6307-00-021 62178731 6307-00-021 62183228 6307-00-021 62180483 6307-00-021 62185696 6307-00-021 62181538 6307-00-021 62188142 6307-00-021 11007719 6307-00-021 62189950 6307-00-021 62193587 6307-00-021 62190389 6307-00-021 62192798 6307-00-021 62196210 6307-00-021 62194526 6307-00-021 11007656 6307-00-021 62200791 6307-00-021 62203902 6307-00-021 62206609 6307-00-021 11007666 6307-00-021 62191204 6307-00-021 11007831 6307-00-021 11007677 6307-00-021 11007922 6307-00-021 11007925 6307-00-021 11007944 6307-00-021 62210574 6307-00-021 62208953 6307-00-021 62210107 6307-00-021 62207438 6307-00-021 11008018

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

47 other products · FDA event 78706

This product is part of a recall event; the main page for the event is Cpt 12/14 Cocr Size 0 Std prosthesis, hip, semi-constrained recalled.

Reported	Class	Recall	Company	Reason	Where
21 Mar 2018	CLASS II	Cpt 12/14 Cocr Size 0 Std prosthesis, hip, semi-constrained recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded FC 13X160MM LM Body Ext Neck & Std Neck recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Lps Precoat Fem Size D-rt Lps Precoat Fem Size E-rt Lps recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr Option Fem Comp Size C/l Cr Option Fem Comp Size C/r Cr recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Lps-flex Option Femoral C-l Lps-flex Option Femoral C-l recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr-flex Por Hatcp Fem C-l Cr-flex Por Hatcp Fem C-r Cr-flex recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Lps-flex Gsf Opt Sz C-l¿ Lps-flex Gsf Opt Sz C-r¿ recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Fem Prc Lt M/rt L Sml Fem Prc Rt M/lt L Sml Fem Prc Lt M/rt recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Bipolar is indicated in: Total hip replacement recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr Precoat Fem Comp Size Bmr Cr Precoat Fem Comp Size C/r recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Lps-flex Precoat Femoral B-r Lps-flex Precoat Femoral C-l recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded Fc 12x200mm Str Std Body/neck 13x200mm Str recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded FC 15X160MM Std Body Std Neck Prosthesis, Hip recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded Fc +10 Calcar 13.5x180mm Str +10 Calcar recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr-flx Por Hatcp Fem C-l Minus Cr-flx Por Hatcp Fem C-r recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded Fc 12x160mm Lm Body Ext Neck Versys Beaded recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Lcck Fem Implant Sz C-l Lcck Fem Implant Sz C-r Lcck Fem recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr-flex Opt Fem C-l Cr-flex Opt Fem C-r Cr-flex Opt Fem D-l recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded FC Rev 13.5X250MM Bwd LT recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Gender Solutions Natural-knee Flex System Femoral recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr-flex Gsf Pct Sz C-r Minus¿ Cr-flex Gsf Pct Sz D-l recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr-flex Por Fem F-l Cr-flex Por Fem F-r Minus Cr-flex Por recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Patello-femoral Joint System Gender Solutions recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cpt 12/14 Cocr Revision Size 2 prosthesis, hip recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr-flex Pct Fem C-r Minus Cr-flex Pct Fem D-l Minus Cr-flex recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Lps Porous Fem Implant SZ G-l Lps Precoat Fem Implant SZ recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cpt 12/14 Cocr Size 2 Ext prosthesis, hip, semi-constrained recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	LPS FEM Implant SZ H-R This device is indicated recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Lps Option Femoral C-l Lps Option Femoral C-r Lps Option recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded FC 14X160MM Std Body Ext & Std Neck recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	CR Por Fem Hatcp Size E/L Size F/L Knee Prosthesis recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded FC Rev 13.5X190MM Straight Prosthesis, Hip recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Nexgen Lps-flex Precoat Femoral Size E-lt This device recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Zimmer Patella Femoral Joint¿ Osteoarthritis recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Lps Precoat Srf Hdn Fem Sz D-l Lps Precoat Srf Hdn Fem Sz recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Nexgen Gsf Porous Femoral Lps Flex Size F recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr-flex Opt Fem C-r Minus Cr-flex Opt Fem D-l Minus Cr-flex recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded Fc Rev 15.0x250mm Bwd Lt & Rt Versys Beaded recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Prct Mis Cr Mob Plt Sz¿ Prct Mis Cr Mob Plt Sz¿ Prct Mis recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Zuk Prc Fem Szb Rmed/llat¿ Zuk Prc Fem Szc Lmed/rlat¿ Zuk recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Lps Fem Comp Sz B-l Lps Fem Comp Sz B-r Lps Fem Comp Sz C-l recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr-flex Pct Fem B-r Cr-flex Pct Fem C-l Cr-flex Pct Fem C-r recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cpt 12/14 Cocr Size 2 Std prosthesis, hip, semi-constrained recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cr-flex Gsf Precoat Sz C-l¿ Cr-flex Gsf Precoat Sz C-r¿ recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Cpt 12/14 Cocr Size 1 Ext prosthesis, hip, semi-constrained recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Gender Solutions Natural-knee Flex System Gender Solutions recalled	Zimmer Biomet	Packaging Defects	Nationwide
21 Mar 2018	CLASS II	Versys Beaded FC Stem 12X160MM LM 13X160MM LM 15X160MM LM recalled	Zimmer Biomet	Packaging Defects	Nationwide

More recalls from Zimmer Biomet

All 873

Reported	Class	Recall	Company	Reason	Where
30 Dec 2020Device	CLASS II	Spinal Rod Cutter recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
23 Dec 2020Device	CLASS II	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recalled	Zimmer Biomet	Device Malfunction	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D. recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide