FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: XP-CR Tibial Tray - Interlok 63mm Item # 195269
- Recall number
- Z-2504-2019
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- XP-CR Tibial Tray - Interlok 63mm Item # 195269
- Status
- Terminated
- Initiated
- 2019-08-15
- Posted
- not on file
- Terminated
- 2021-04-16
- Reason
- The locking bar not fully engaging
- Root cause
- Manufacturing material removal
- Action
- 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-
- Quantity
- 322 unit
- 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
- Lot, serial or model codes
- Lot Number 663420 993820 660430 660430R 262380 395340 445350 584240 562230 578990 579070 043840 159200 917670 996050 043840R 917670R 206800 090150 159210 352790 995940 352780 469480 321920 663450 258040 352770 966700 434250 434260 456730 274630 374760 672430 899750 041270 899710 041200 666860 278990 600750 712530 600750R 821250 821250R 450310 599050 599050R 199780 717140 943340 017920 076390 220020 220020R 175270 228580 175270R 199790 199790R 395350
- 510(k) numbers
- ["K132873"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28