Recalls / —

—#175823

Product

XP-CR Tibial Tray - Interlok 67mm Item # 195271

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K132873

Affected lot / code info

Lot Number 486100 262400 291180 584260 663550 562250 666830 660450 841520 917700 966720 966720R 075450 075460 075500 663530 995960 322020 043860 090190 206820 075440 745670 352820 383680 075470 745650 513340 159230 258060 429230 161960 161950 161930 161910 161920 162010 161860 274480 161870 161900 274460 996070 274490 274510 721690 322000 456750 456750R 274470 374780 951150 075510 469490 721670 309710 274500 309680 309690 075490 309700 585540 883560 221140 374030 920540 279010 450330 672510 575980 821280 943360 599120 600770 712550 717160 017970 076400 076410 220040 175290 175290R 289160 676270 676300 228610 351290 395400 395420 445370 395400R

Why it was recalled

The locking bar not fully engaging

Root cause (FDA determination)

Manufacturing material removal

Action the firm took

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-

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

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

Timeline

Recall initiated

2019-08-15

Terminated

2021-04-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #175823. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.