CLASS II Device recall · Reported 18 Sep 2019 · FDA Enforcement Report

Xp-cr Tibial Tray - Interlok recalled by Zimmer Biomet

Zimmer Biomet is recalling Xp-cr Tibial Tray - Interlok, distributed in 39 states. The recall was initiated on 15 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 663820 503480 262450 308140 308150 473010 513130 320340 320590 579060 571060 938200 322150 066240 283270 322200 851360 996030 996030R 090250 841560 206870 322180 258110 279270 553900 711510 161980 161990 274450 043940 041260 663840 041170 993800 883570 883600 883590 883580 888420 374120 599170 576060 279060 712600 576050 672660 821370 600820 717210 943420 221180 141500 199770 450380 220060 502880 513120
Quantity recalled319 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2511-2019
FDA event ID
83594
Recalling firm
Zimmer Biomet, Warsaw, IN
Classification
Class II
Status
Terminated
Recall initiated
15 Aug 2019
FDA classified
12 Sep 2019
Reported
18 Sep 2019
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

15 Aug 2019Recall initiated by company
12 Sep 2019Classified by FDA+28 days
18 Sep 2019Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The locking bar not fully engaging

Product as listed by the FDA

XP-CR Tibial Tray - Interlok 79 mm Item # 195276

Where it was distributed

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

AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippi

Questions about this recall

Is Xp-cr Tibial Tray - Interlok recalled?

Yes. Zimmer Biomet recalled Xp-cr Tibial Tray - Interlok on 15 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-2511-2019.

Why was it recalled?

The locking bar not fully engaging

Which lots are affected?

Lot Number 663820 503480 262450 308140 308150 473010 513130 320340 320590 579060 571060 938200 322150 066240 283270 322200 851360 996030 996030R 090250 841560 206870 322180 258110 279270 553900 711510 161980 161990 274450 043940 041260 663840 041170 993800 883570 883600 883590 883580 888420 374120 599170 576060 279060 712600 576050 672660 821370 600820 717210 943420 221180 141500 199770 450380 220060 502880 513120

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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