Zimmer Biomet, Inc.: XP-CR Tibial Tray - Interlok 71mm Item # 195273

Recall number

Z-2508-2019

Recalling firm

Zimmer Biomet, Inc.

Product

XP-CR Tibial Tray - Interlok 71mm Item # 195273

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

454 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 663640 262420 571030 590700 590710 676280 917650 320580 966740 995980 996090 966740R 043890 159270 206840 258080 283210 841530 043900 066200 090220 066200R 322070 322070R 383700 352840 283180 359640 322090 429260 374800 403830 159260 456770 041150 579240 899740 274590 274530 274580 041240 041190 503440 585580 993810 666890 503460 888430 221170 985320 374080 374070 279030 599140 576020 943390 821310 411240 450350 600790 712570 717180 717180R 018020 111590 676310 676310R 072520 218650 291200 072520R 672570 289190 562280 148430 291190 351320 445400 445410 486120 445400R 445410R

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

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

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