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-2513-2019
- 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 87 mm Item # 195278
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
Why was it recalled?
The locking bar not fully engaging
Which lots are affected?
Lot Number 966230 262470 587200 274370 274360 274380 274420 715690 274420R 715690R 393650 279080 394490 821380 903430 943440 422480 512580
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
34 other products · FDA event 83594This product is part of a recall event; the main page for the event is Xp-xp Tibial Tray - Interlok recalled by Zimmer Biomet.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |