CLASS II Device recall · Reported 1 Mar 2017 · FDA Enforcement Report
Oxford Partial Knee System Right Medial Tibial Trial Tray Size E recalled
Biomet U.K is recalling Oxford Partial Knee System Right Medial Tibial Trial Tray Size E, distributed in 14 states. The recall was initiated on 5 Jan 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-1160-2017
- FDA event ID
- 76179
- Recalling firm
- Biomet U.K, Bridgend South Wales, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jan 2016
- FDA classified
- 22 Feb 2017
- Reported
- 1 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Hip & Knee Implants
Timeline
| 5 Jan 2016 | Recall initiated by company | |
| 22 Feb 2017 | Classified by FDA | +414 days |
| 1 Mar 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 is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
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
Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Where it was distributed
Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
ArkansasCaliforniaKansasKentuckyLouisianaMassachusettsMissouriMontanaNorth CarolinaNew JerseyNew YorkOklahomaSouth CarolinaTexas
Questions about this recall
Is Oxford Partial Knee System Right Medial Tibial Trial Tray Size E recalled?
Yes. Biomet U.K recalled Oxford Partial Knee System Right Medial Tibial Trial Tray Size E on 5 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-1160-2017.
Why was it recalled?
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Which lots are affected?
Item: 32-420737, Lots: ZB160501, ZB160601, ZB160801
Where was it sold?
Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, 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.
More recalls from Biomet U.K
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Oxford Unicompartmental Knee Phase 3 Shim Size recalled by Biomet U.K | Biomet U.K | Lead & Heavy Metals | 14 states |
| Device | CLASS II | Oxford Knee System Tibial Resector Body Tube & Guides recalled | Biomet U.K | Lead & Heavy Metals | 14 states |
| Device | CLASS II | Oxford Partial Knee System Right Medial Tibial Trial Tray Size D recalled | Biomet U.K | Lead & Heavy Metals | 14 states |
| Device | CLASS II | Oxford Partial Knee System Phase 3 Tibial Template Right recalled | Biomet U.K | Lead & Heavy Metals | 14 states |
| Device | CLASS II | Oxford Partial Knee System Right Medial Tibial Trial Tray Size B recalled | Biomet U.K | Lead & Heavy Metals | 14 states |
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 | Nitrosamine Impurity | 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) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |