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-2508-2019
- 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 71mm Item # 195273
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 663640 262420 571030 590700 590710 676280 917650 320580 966740 995980 996090 966740R 043890 159270 206840 258080 283210 841530 043900 066200 090220 066200R 322070 322070R 383700 352840 283180 359640 322090 429260 374800 403830 159260 456770 041150 579240 899740 274590 274530 274580 041240 041190 503440 585580 993810 666890 503460 888430 221170 985320 374080 374070 279030 599140 576020 943390 821310 411240 450350 600790 712570 717180 717180R 018020 111590 676310 676310R 072520 218650 291200 072520R 672570 289190 562280 148430 291190 351320 445400 445410 486120 445400R 445410R
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 |