Device recall: XP- CR Tibial Tray- Interlok 59mm Item # 195268
Class II FDA enforcement event 83594. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The locking bar not fully engaging
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
Zimmer Biomet, Inc. started this device recall on 15 Aug 2019. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 83594 has 35 product records. The first FDA enforcement report date is 18 Sep 2019. The record gives the status Terminated, with the termination date 16 Apr 2021.
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.
State NY IN OH MI GA SC FL MO WI MN ND SD NE NJ PA MD IL IA CA VA NC DC WV AR AL MS AL MI WA OR ID LA FL KS TN MA KY OK TX TX CT AZ NV NM MT WY CO UT DC WY Country: KOREA CHINA CANADA AUSTRALIA…
Recalling firm
Zimmer Biomet, Inc., Warsaw, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
35 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2503-2019 | XP- CR Tibial Tray- Interlok 59mm Item # 195268 | 45 units | Class II | Terminated | 18 Sep 2019 |
| Z-2504-2019 | XP-CR Tibial Tray - Interlok 63mm Item # 195269 | 322 unit | Class II | Terminated | 18 Sep 2019 |
| Z-2505-2019 | XP-CR Tibial Tray - Interlok 65mm Item # 195270 | 375 units | Class II | Terminated | 18 Sep 2019 |
| Z-2506-2019 | XP-CR Tibial Tray - Interlok 67mm Item # 195271 | 567 units | Class II | Terminated | 18 Sep 2019 |
| Z-2507-2019 | XP-CR Tibial Tray - Interlok 69mm Item # 195272 | 498 units | Class II | Terminated | 18 Sep 2019 |
| Z-2508-2019 | XP-CR Tibial Tray - Interlok 71mm Item # 195273 | 454 units | Class II | Terminated | 18 Sep 2019 |
| Z-2509-2019 | XP-CR Tibial Tray - Interlok 73mm Item # 195274 | 327 units | Class II | Terminated | 18 Sep 2019 |
| Z-2510-2019 | XP-CR Tibial Tray - Interlok 75mm Item # 195275 | 369 units | Class II | Terminated | 18 Sep 2019 |
| Z-2511-2019 | XP-CR Tibial Tray - Interlok 79 mm Item # 195276 | 319 units | Class II | Terminated | 18 Sep 2019 |
| Z-2512-2019 | XP-CR Tibial Tray - Interlok 83 mm Item # 195277 | 180 units | Class II | Terminated | 18 Sep 2019 |
| Z-2513-2019 | XP-CR Tibial Tray - Interlok 87 mm Item # 195278 | 78 units | Class II | Terminated | 18 Sep 2019 |
| Z-2514-2019 | XP-CR Tibial Tray - Interlok 91 mm Item # 195279 | 82 units | Class II | Terminated | 18 Sep 2019 |
| Z-2515-2019 | XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291 | 2 units | Class II | Terminated | 18 Sep 2019 |
| Z-2516-2019 | XP-XP Tibial Tray - Interlok 91mm Item # 195761 | 86 units | Class II | Terminated | 18 Sep 2019 |
| Z-2517-2019 | XP-XP Tibial Tray - Interlok 87 mm Item # 195760 | 90 units | Class II | Terminated | 18 Sep 2019 |
| Z-2518-2019 | XP-XP Tibial Tray - Interlok 83 mm Item # 195759 | 384 units | Class II | Terminated | 18 Sep 2019 |
| Z-2519-2019 | XP-XP Tibial Tray - Interlok 79 mm Item # 195758 | Class II | Terminated | 18 Sep 2019 | |
| Z-2520-2019 | XP-XP Tibial Tray - Interlok 75 mm Item # 195757 | 973 units | Class II | Terminated | 18 Sep 2019 |
| Z-2521-2019 | XP-XP Tibial Tray - Interlok 73 mm Item # 195756 | 906 units | Class II | Terminated | 18 Sep 2019 |
| Z-2522-2019 | XP-XP Tibial Tray - Interlok 71 mm Item # 195755 | 1221 units | Class II | Terminated | 18 Sep 2019 |
| Z-2523-2019 | XP-XP Tibial Tray - Interlok 69 mm Item # 195754 | 1282 units | Class II | Terminated | 18 Sep 2019 |
| Z-2524-2019 | XP-XP Tibial Tray - Interlok 67 mm Item # 195753 | 1210 units | Class II | Terminated | 18 Sep 2019 |
| Z-2525-2019 | XP-XP Tibial Tray - Interlok 65 mm Item # 195752 | 857 units | Class II | Terminated | 18 Sep 2019 |
| Z-2526-2019 | XP-XP Tibial Tray - Interlok 63 mm Item # 195751 | 480 units | Class II | Terminated | 18 Sep 2019 |
| Z-2527-2019 | XP-XP Tibial Tray - Interlok 59 mm Item # 195750 | 50 units | Class II | Terminated | 18 Sep 2019 |
| Z-2528-2019 | Vanguard XP Tibial Tray 63 mm Item # 195245 | 8 units | Class II | Terminated | 18 Sep 2019 |
| Z-2529-2019 | Vanguard XP Tibial Tray 65 mm Item # 195246 | 43 units | Class II | Terminated | 18 Sep 2019 |
| Z-2530-2019 | Vanguard XP Tibial Tray 67 mm Item # 195247 | 74 units | Class II | Terminated | 18 Sep 2019 |
| Z-2531-2019 | Vanguard XP Tibial Tray 69 mm Item # 195248 | 123 units | Class II | Terminated | 18 Sep 2019 |
| Z-2532-2019 | Vanguard XP Tibial Tray 71 mm Item # 195249 | Class II | Terminated | 18 Sep 2019 | |
| Z-2533-2019 | Vanguard XP Tibial Tray 73 mm Item # 195250 | 84 units | Class II | Terminated | 18 Sep 2019 |
| Z-2534-2019 | Vanguard XP Tibial Tray 75 mm Item # 195251 | 110 units | Class II | Terminated | 18 Sep 2019 |
| Z-2535-2019 | Vanguard XP Tibial Tray 79 mm Item # 195252 | 99 units | Class II | Terminated | 18 Sep 2019 |
| Z-2536-2019 | Vanguard XP Tibial Tray 83 mm Item # 195253 | 49 units | Class II | Terminated | 18 Sep 2019 |
| Z-2537-2019 | Vanguard XP Tibial Tray 87 mm Item # 195254 | Class II | Terminated | 18 Sep 2019 |
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 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 35Median of the firm: 1
- Events of the firm on the register
- 144
Other events of the firm
Official channels
- FDA enforcement report Z-2503-2019The 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 83594. https://recallregister.com/fda/ii/83594/. 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:
State NY IN OH MI GA SC FL MO WI MN ND SD NE NJ PA MD IL IA CA VA NC DC WV AR AL MS AL MI WA OR ID LA FL KS TN MA KY OK TX TX CT AZ NV NM MT WY CO UT DC WY Country: KOREA CHINA CANADA AUSTRALIA…
- What quantity of product is in FDA event 83594?
- The event has 35 product records. The first record gives this quantity:
45 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.