CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report
M/L Taper Hip Prosthesis recalled by Zimmer Biomet
Zimmer Biomet is recalling M/L Taper Hip Prosthesis (, distributed in 7 states. The recall was initiated on 11 Feb 2016 and the FDA has classified it as Class II.
Check your package
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-1046-2016
- FDA event ID
- 73298
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Feb 2016
- FDA classified
- 4 Mar 2016
- Reported
- 16 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 11 Feb 2016 | Recall initiated by company | |
| 4 Mar 2016 | Classified by FDA | +22 days |
| 16 Mar 2016 | Published in enforcement report | +12 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 initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.
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
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Where it was distributed
Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
KentuckyMichiganMissouriNew YorkPennsylvaniaSouth DakotaTennessee
Questions about this recall
Is M/L Taper Hip Prosthesis ( recalled?
Yes. Zimmer Biomet recalled M/L Taper Hip Prosthesis ( on 11 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1046-2016.
Why was it recalled?
Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.
Which lots are affected?
Item: 00-7711-012-20, Lot: 62937093
Where was it sold?
Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
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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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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