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
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-2510-2019
- 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
- Device type
- Hip & Knee Implants
Timeline
| 15 Aug 2019 | Recall initiated by company | |
| 12 Sep 2019 | Classified by FDA | +28 days |
| 18 Sep 2019 | Published 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 75mm Item # 195275
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-2510-2019.
Why was it recalled?
The locking bar not fully engaging
Which lots are affected?
Lot Number 663790 262440 513090 590770 590780 590790 663740 663770 917760 206860 938190 966780 206860R 043930 066230 090240 851340 322130 258100 283250 434280 434280R 429280 456780 513110 434270 996020 374820 469540 041250 666900 041160 579270 503470 503450 503410 576030 279050 599160 672640 374100 821350 821350R 450370 600810 712590 717200 600810R 717200R 148450 199750 676260 676330 676290 562300 562300R 279260 308120 308130 473000 502860 553890 571050 279260R 308120R 473000R
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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|---|---|---|---|---|---|
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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |