CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report

Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa recalled

Zimmer Biomet is recalling Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, distributed nationwide in the US. The recall was initiated on 13 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFinished Lot order: M370490 M354450 M321540 M975460 M639280 M426760 M629950 M629930 M073530 M073540 M073550 M073560 M073570 M073580 M073590 M073600 M073610 M627490 M656470 M656580 M656590 M656600 M656610 M656620 M656640 M656660 M966880 M967050 M967060 M967070 M980260 M980270 M508490 M508410 M508500 M508450 M508480 M508520 M508470 M508510 M508460

Quantity recalled337 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-0773-2018
FDA event ID: 79146
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 13 Sep 2017
FDA classified: 27 Feb 2018
Reported: 7 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

13 Sep 2017	Recall initiated by company
27 Feb 2018	Classified by FDA	+167 days
7 Mar 2018	Published in enforcement report	+8 days

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

Reason for recall

Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.

Product as listed by the FDA

Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument

Where it was distributed

Distribution includes US Nationwide.

Nationwide

Questions about this recall

Is Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa recalled?

Yes. Zimmer Biomet recalled Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa on 13 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-0773-2018.

Why was it recalled?

Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.

Which lots are affected?

Finished Lot order: M370490 M354450 M321540 M975460 M639280 M426760 M629950 M629930 M073530 M073540 M073550 M073560 M073570 M073580 M073590 M073600 M073610 M627490 M656470 M656580 M656590 M656600 M656610 M656620 M656640 M656660 M966880 M967050 M967060 M967070 M980260 M980270 M508490 M508410 M508500 M508450 M508480 M508520 M508470 M508510 M508460

Where was it sold?

Distribution includes US Nationwide.

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.

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