Recall Z-2527-2019
Zimmer Biomet, Inc. · initiated August 15, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
XP-XP Tibial Tray - Interlok 59 mm Item # 195750
Codes / lots: Lot Number 206540 057180 206590 206580 206550 030800 206560 457940 457880 457930 457970 457950
Reason for recall
The locking bar not fully engaging
FDA-determined cause: Manufacturing material removal
Action taken
Risk Manager Responsibilities: 1.Review this notification and ensure that affected personnel are aware of the contents. 2.If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3.Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4.Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5.If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1.Review this notification for awareness of the contents. 2.There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3.A visual and audible confirmation should be made to ensure complete locking bar insertion. 4.Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 5.Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 6.If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-
Details
- Recall number
- Z-2527-2019
- Initiated
- August 15, 2019
- Terminated
- April 16, 2021
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 50 units
- 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 JAPAN EMEA SWEDEN ITALY
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2503-2019 Class II | XP- CR Tibial Tray- Interlok 59mm Item # 195268The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2504-2019 Class II | XP-CR Tibial Tray - Interlok 63mm Item # 195269The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2505-2019 Class II | XP-CR Tibial Tray - Interlok 65mm Item # 195270The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2506-2019 Class II | XP-CR Tibial Tray - Interlok 67mm Item # 195271The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2507-2019 Class II | XP-CR Tibial Tray - Interlok 69mm Item # 195272The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2508-2019 Class II | XP-CR Tibial Tray - Interlok 71mm Item # 195273The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2509-2019 Class II | XP-CR Tibial Tray - Interlok 73mm Item # 195274The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2510-2019 Class II | XP-CR Tibial Tray - Interlok 75mm Item # 195275The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2511-2019 Class II | XP-CR Tibial Tray - Interlok 79 mm Item # 195276The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2512-2019 Class II | XP-CR Tibial Tray - Interlok 83 mm Item # 195277The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2513-2019 Class II | XP-CR Tibial Tray - Interlok 87 mm Item # 195278The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2514-2019 Class II | XP-CR Tibial Tray - Interlok 91 mm Item # 195279The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2515-2019 Class II | XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2516-2019 Class II | XP-XP Tibial Tray - Interlok 91mm Item # 195761The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2517-2019 Class II | XP-XP Tibial Tray - Interlok 87 mm Item # 195760The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2518-2019 Class II | XP-XP Tibial Tray - Interlok 83 mm Item # 195759The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2519-2019 Class II | XP-XP Tibial Tray - Interlok 79 mm Item # 195758The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2520-2019 Class II | XP-XP Tibial Tray - Interlok 75 mm Item # 195757The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2521-2019 Class II | XP-XP Tibial Tray - Interlok 73 mm Item # 195756The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2522-2019 Class II | XP-XP Tibial Tray - Interlok 71 mm Item # 195755The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2523-2019 Class II | XP-XP Tibial Tray - Interlok 69 mm Item # 195754The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2524-2019 Class II | XP-XP Tibial Tray - Interlok 67 mm Item # 195753The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2525-2019 Class II | XP-XP Tibial Tray - Interlok 65 mm Item # 195752The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2526-2019 Class II | XP-XP Tibial Tray - Interlok 63 mm Item # 195751The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2528-2019 Class II | Vanguard XP Tibial Tray 63 mm Item # 195245The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2529-2019 Class II | Vanguard XP Tibial Tray 65 mm Item # 195246The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2530-2019 Class II | Vanguard XP Tibial Tray 67 mm Item # 195247The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2531-2019 Class II | Vanguard XP Tibial Tray 69 mm Item # 195248The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2532-2019 Class II | Vanguard XP Tibial Tray 71 mm Item # 195249The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2533-2019 Class II | Vanguard XP Tibial Tray 73 mm Item # 195250The locking bar not fully engaging | 08/15/2019Terminated |