CLASS II Device recall · Reported 18 Sep 2019 · FDA Enforcement Report
Xp-xp Tibial Tray - Interlok recalled by Zimmer Biomet
Zimmer Biomet is recalling Xp-xp 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-2522-2019
- 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-XP Tibial Tray - Interlok 71 mm Item # 195755
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 450440 590880 512630 820720 820750 841600 841620 664320 841610 972770 589900 660500 664300 664310 677650 841580 664300R 972750 998070 758320 044000 841590 044020 066160 677640 066150 381750 420270 664330 381750R 381730 433990 374560 282790 374540 420280 433960 381740 358960 758290 468150 505080 036280 998080 089890 358970 374570 499170 505060 358970R 374570R 322450 282800 499150 420250 499160 499180 592370 468140 505070 592380 592350 322460 036270 505050 840730 885090 840710 855340 864720 885080 592360 592400 916860 958440 916850 828720 975610 958430 011470 023380 061400 061410 984770 181440 103040 181420 103030 131230 159310 061420 116010 116030 261080 293870 241450 297200 336140 293850 223150 241440 261090 384230 336980 337000 093400 223130 201950 297070 371590 336130 556580 587300 371560 418730 432380 384220 467200 511470 599810 599810R 634230 664180 684930 705650 715820 716100 715830 715840 715840R 882100 920600 906730 906720 029270 072940 985950 072920 126020 985940 396390 126010 163000 163010 247340 247360 247350 221400 293130 318540 293120 318530 336720 318510 336710 374470 374490 390050 318520 390070 570260 478910 478920 478940 441940 441950 441960 509740 543370 543350 509780 593630 625550 522640 576160 576170 593620 625570 639660 639670 670580 708620 670590 708540 741540 780230 758540 808280 522660 560360 780210 808300 570270 741530 758530 850950 850940 833190 873550 873540 917630 999330 999340 018150 999470 076700 111700 917640 943540 950970 999460 076690 111710 183520 481870 481880 559030 481880R 072650 137510 191160 219820 289240 562190 613400 650440 650450 422520
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 |