CLASS II Device recall · Reported 26 Mar 2014 · FDA Enforcement Report

Natural-Knee¿ II - Unicompartmental Knee Prosthesis recalled by Zimmer

Zimmer is recalling Natural-Knee¿ II - Unicompartmental Knee Prosthesis: Cong Tib Ins SZ1/2 UN Cong Tib Ins, distributed nationwide in the US. The recall was initiated on 25 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Number 611001009 611001011 611001013 611002009 611002011 611002013 611003009 611003011 611003013

Quantity recalled3638 units

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-1251-2014
FDA event ID: 67503
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 25 Feb 2014
FDA classified: 20 Mar 2014
Reported: 26 Mar 2014
Type: Voluntary: Firm initiated
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

25 Feb 2014	Recall initiated by company
20 Mar 2014	Classified by FDA	+23 days
26 Mar 2014	Published in enforcement report	+6 days

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

Reason for recall

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB INS SZ3/4 13MM U CONG TIB INS SZ 5/6 9MM U CONG TIB INS SZ5/6 11MM U CONG TIB INS SZ5/6 13MM U

Where it was distributed

Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Illinois Indiana Kansas Louisiana Maine Michigan Missouri Mississippi North Carolina North Dakota Nebraska

Questions about this recall

Why was it recalled?

Which lots are affected?

Item Number 611001009 611001011 611001013 611002009 611002011 611002013 611003009 611003011 611003013

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

14 other products · FDA event 67503

This product is part of a recall event; the main page for the event is Natural-Knee¿/Apollo" Knee recalled by Zimmer.

Reported	Class	Recall	Company	Reason	Where
26 Mar 2014	CLASS II	Natural-Knee¿/Apollo" Knee recalled by Zimmer	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Natural-Knee¿ II Posterior Stabilized recalled by Zimmer	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Apollo Knee Tibial Baseplate/Knee Tibial Insert recalled by Zimmer	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Natural-Knee¿ N-k II Domed All-poly Pat recalled by Zimmer	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Most Options" System (Most) Hinged Tib Ins SZ 1 Hinged Tib recalled	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Natural-Knee¿ Congruent Tibial Insert with Screw recalled by Zimmer	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Natural-Knee¿ II Unicompartmental Knee System recalled by Zimmer	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Natural-Knee¿ II Constrained Knee System Nkii Cck Tib Ins recalled	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Gender Solutions" Natural-Knee¿ Flex System recalled by Zimmer	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Natural-Knee¿ II System Ultra Cong Ins LT Sza/ Ultra Cong recalled	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Apollo" Revision/Constrained Knee System recalled by Zimmer	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Natural-Knee¿ II System: Poly Ultra Tib LT SZ00/9M Poly recalled	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Apollo" Knee System: PS Tib Ins SZ0/ Apoll PS Tib Ins SZ0 recalled	Zimmer	Sterility	Nationwide
26 Mar 2014	CLASS II	Apollo" Knee System: Apollo Patella SZ0 R recalled by Zimmer	Zimmer	Sterility	Nationwide

More recalls from Zimmer

All 539

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	Off-Axis Comprehensive Shoulder System, Large, Augment recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Off-Axis Comprehensive Shoulder System Small, Augment recalled by Zimmer	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled	Zimmer	Packaging Defects	IN
1 Jul 2026Device	CLASS II	Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	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