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-1738-2019
- 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
- Other Reasons
- 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.
Product as listed by the FDA
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
Where it was distributed
CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS
Questions about this recall
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: ZB161102 ZB170201 ZB170301 ZB170401 ZB170901
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 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
5 other products · FDA event 82818This product is part of a recall event; the main page for the event is Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral recalled | Zimmer Biomet | Other | 7 states | |
| CLASS II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral recalled | Zimmer Biomet | Other | 7 states | |
| CLASS II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral recalled | Zimmer Biomet | Other | 7 states | |
| CLASS II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral recalled | Zimmer Biomet | Other | 7 states | |
| CLASS II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral recalled | Zimmer Biomet | Other | 7 states |
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|---|---|---|---|---|---|
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| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Other | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |