Zimmer Biomet, Inc.: XP-XP Tibial Tray - Interlok 63 mm Item # 195751

Recall number

Z-2526-2019

Recalling firm

Zimmer Biomet, Inc.

Product

XP-XP Tibial Tray - Interlok 63 mm Item # 195751

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

480 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 522520 571140 589700 758150 028960 028980 043970 028980R 043970R 064960 028970 065200 101860 101880 065200R 433940 321620 321640 321620R 321640R 433910 592120 592140 592150 592170 257970 592180 801960 282710 282710R 282690 801940 801950 783060 783040 011410 975550 592110 984660 023340 257960 840190 061310 592160 102990 223050 261130 336080 585400 585370 511430 467140 684820 664140 634080 705510 715730 716030 716030R 920550 881940 029210 906640 985880 072790 125870 162880 396240 318430 247250 336660 441870 374320 587220 509590 543180 543150 708390 576080 639600 670510 522580 558990 593560 450400 741460 758480 780160 808130 833150 873470 943480 850880 917590 183370 560280 570170 570180 570180R 076640 191080 111620 950910 963430 999270 018060 261910 613310 650370

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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