FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: XP-CR Tibial Tray - Interlok 75mm Item # 195275
- Recall number
- Z-2510-2019
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- XP-CR Tibial Tray - Interlok 75mm Item # 195275
- 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
- 369 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
- Lot, serial or model codes
- Lot Number 663790 262440 513090 590770 590780 590790 663740 663770 917760 206860 938190 966780 206860R 043930 066230 090240 851340 322130 258100 283250 434280 434280R 429280 456780 513110 434270 996020 374820 469540 041250 666900 041160 579270 503470 503450 503410 576030 279050 599160 672640 374100 821350 821350R 450370 600810 712590 717200 600810R 717200R 148450 199750 676260 676330 676290 562300 562300R 279260 308120 308130 473000 502860 553890 571050 279260R 308120R 473000R
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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