CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral recalled
Zimmer Biomet is recalling Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide, distributed in 7 states. The recall was initiated on 18 Apr 2019 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-1741-2019
- FDA event ID
- 82818
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Apr 2019
- FDA classified
- 6 Jun 2019
- Reported
- 12 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Hip & Knee Implants
Timeline
| 18 Apr 2019 | Recall initiated by company | |
| 6 Jun 2019 | Classified by FDA | +49 days |
| 12 Jun 2019 | 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
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small
Where it was distributed
CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS
Questions about this recall
Is Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide recalled?
Yes. Zimmer Biomet recalled Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide on 18 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1741-2019.
Why was it recalled?
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Which lots are affected?
Lot Numbers: ZB160101 ZB160801 ZB160801
Where was it sold?
CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS
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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