Recalls / —

—#175822

Product

XP-CR Tibial Tray - Interlok 65mm Item # 195270

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 666880 660440 579080 579170 993790 262390 228590 584250 289150 579150 663480 996060 663480R 043850 090170 917690 159220 321940 352810 374770 600760 663500 841510 076020 352800 383660 429220 966710 321970 456740 456740R 995950 258050 274610 274600 403820 206810 041210 899720 899760 585520 585520R 041280 503430 437500 503490 503420 247240 247240R 374010 712540 672470 279000 575960 017940 450320 599100 717150 599100R 943350 821270 111560 220030 175280 199800 199810 175280R 395360 395370 395390 445360 395390R

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 #175822. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.