CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report

Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation recalled by Zimmer Biomet

Zimmer Biomet is recalling Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific, distributed nationwide in the US. The recall was initiated on 28 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Number:00225248015, Lot Number Expiry Date Before: March 2027

Quantity recalledN/A

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-2557-2017
FDA event ID: 76629
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 28 Feb 2017
FDA classified: 14 Jun 2017
Reported: 21 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

28 Feb 2017	Recall initiated by company
14 Jun 2017	Classified by FDA	+106 days
21 Jun 2017	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

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

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

Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Where it was distributed

Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand

Nationwide

Questions about this recall

Why was it recalled?

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

Which lots are affected?

Item Number:00225248015, Lot Number Expiry Date Before: March 2027

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 21 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

34 other products · FDA event 76629

This product is part of a recall event; the main page for the event is Por fullct fem st 17x200mm, Sterile recalled by Zimmer Biomet.

Reported	Class	Recall	Company	Reason	Where
21 Jun 2017	CLASS II	Por fullct fem st 17x200mm, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental fluted stem, 17x190mm str, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental malefemale taper, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental fluted stem, 18x190mm str, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental fluted stem, 19x190mm str, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental fluted stem, 16x250mm bwd, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental fluted stem, 15x250mm bwd, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Por fullct fem st 18x200mm, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Por fullct fem st 15x200mm, Sterile, prosthesis, hip recalled	Zimmer Biomet	Foreign Material	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Por fullct fem st 20x200mm, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental malefemale taper, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Por fullct fem st 20x200mm, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental vss bowed 19x190mm, Sterile, Hip joint recalled	Zimmer Biomet	Foreign Material	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental fluted stem, 17x250mm bwd, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Por fullct fem st 16x200mm, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation recalled	Zimmer Biomet	Sterility	Nationwide
21 Jun 2017	CLASS II	Segmental fluted stem, 18x250mm bwd, Sterile recalled by Zimmer Biomet	Zimmer Biomet	Sterility	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	Sterility	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	Sterility	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Sterility	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Sterility	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	Nitrosamine Impurity	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)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide