Device recall: Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial…
Class II FDA enforcement event 76179. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Biomet U.K., Ltd. started this device recall on 5 Jan 2016. The firm address in the FDA record is in Bridgend South Wales. FDA put the recall in Class II. FDA event 76179 has 24 product records. The first FDA enforcement report date is 1 Mar 2017. The record gives the status Terminated, with the termination date 30 Jun 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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
Recalling firm
Biomet U.K., Ltd., Bridgend South Wales, N/A, United Kingdom.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
24 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1152-2017 | Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1153-2017 | Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1154-2017 | Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1155-2017 | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1156-2017 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1157-2017 | Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1158-2017 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1159-2017 | Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1160-2017 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1161-2017 | Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1162-2017 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 | Class II | Terminated | 1 Mar 2017 |
| Z-1163-2017 | Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1164-2017 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1165-2017 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1166-2017 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1167-2017 | Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1168-2017 | Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1169-2017 | Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1170-2017 | Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1171-2017 | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1172-2017 | Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 | Class II | Terminated | 1 Mar 2017 |
| Z-1173-2017 | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1174-2017 | Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
| Z-1175-2017 | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System | 72 units in total | Class II | Terminated | 1 Mar 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 24Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Mar 2013 | REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System T | Device | Class II | 1 |
| 27 Jul 2012 | Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when prep | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1152-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 76179. https://recallregister.com/fda/ii/76179/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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 quantity of product is in FDA event 76179?
- The event has 24 product records. The first record gives this quantity:
72 units in total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.