Recalls / —

—#175824

Product

XP-CR Tibial Tray - Interlok 69mm Item # 195272

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 562270 579210 663600 262410 445380 584280 590680 660460 663580 190400 190450 190460 190480 190470 190440 190490 190420 663620 996080 663620R 579230 043870 043880 090200 159240 090200R 159250 258070 283160 995970 206830 966730 374790 383690 283150 283150R 590690 352830 429250 322040 469500 456760 041290 827550 827540 585560 041220 503500 076030 221160 374060 221150 279020 712560 576010 672540 374050 821300 943380 450340 599130 600780 717170 017990 111580 111570 821290 220050 289180 121130 202930 218640 199730 351300 395430 395450 439670 445390 486110 351300R 395450R 439670R

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 #175824. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.