Reported Dec 4, 2019 · Terminated
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos.
114754114755114744114745114704114705114756114757114714114715114746114747114706114707114758114759114716114717114748114749114708114709114718114719CP561429CP561430CP561431CP561432CP561442CP561449CP561488CP561489CP561709CP561710CP561714
- CP561715 PM555203 Product UsageTotal Elbow Replacement
- Lot codes and dates
- LOTS
188 of 188 codes
098150098170885530551700582640860410537600998440536200349800020980452110650490632550649570776070411420021170537440850110762800217470349790452100342680367650537660688030192120394130826480829870094600668330997920776390537690129330452180094590630340529650641720418260635230094850418270561370688000143470452090631460766880044090630470188230880350119800418230952290
- UDI(01)00880304436343(17)201208(10)650490 (01)00880304436343(17)201208(10)632550 (01)00880304436343(17)210512(10)649570 (01)00880304436343(17)210606(10)776070 (01)00880304436343(17)210824(10)411420 (01)00880304436343(17)220206(10)021170 (01)00880304435964(17)210425(10)342680 (01)00880304435964(17)210812(10)367650 (01)00880304435933(17)210203(10)094600 (01)00880304435933(17)210822(10)668330 (01)00880304435940(17)210203(10)094590 (01)00880304435940(17)201228(10)630340 (01)00880304435940(17)210219(10)529650 (01)00880304435940(17)210219(10)641720 (01)00880304435940(17)210706(10)418260 (01)00880304435940(17)210723(10)635230 (01)00880304435940(17)210907(10)094850 (01)00880304435940(17)211110(10)418270 (01)00880304434295(17)201228(10)631460 (01)00880304434295(17)210122(10)766880 (01)00880304434295(17)210125(10)044090 (01)00880304434295(17)210407(10)630470 (01)00880304434295(17)210416(10)188230 (01)00880304434295(17)210617(10)880350 (01)00880304434295(17)210620(10)119800 (01)00880304434295(17)210820(10)418230 (01)00880304434295(17)210822(10)952290 (01)00880304434295(17)210822(10)418240 (01)00880304434295(17)211110(10)041340 (01)00880304434295(17)211129(10)209730 (01)00880304434837(17)210310(10)378110 (01)00880304434837(17)210407(10)172700 (01)00880304434837(17)210425(10)630460 (01)00880304434837(17)210607(10)958490 (01)00880304434837(17)210607(10)887520 (01)00880304434837(17)210809(10)367640 (01)00880304435957(17)210107(10)632400 (01)00880304435957(17)210607(10)342690 (01)00880304435957(17)210721(10)691260 (01)00880304435957(17)210721(10)418250 (01)00880304434455(17)210210(10)378140 (01)00880304434455(17)210330(10)630490 (01)00880304434455(17)210906(10)668320 (01)00880304434332(17)201204(10)630280 (01)00880304434332(17)210812(10)776060 (01)00880304434332(17)210906(10)222580 (01)00880304434332(17)210912(10)418220 (01)00880304435056(17)201204(10)648930 (01)00880304435056(17)201204(10)631250 (01)00880304435056(17)210520(10)649560 (01)00880304435056(17)210608(10)880340 (01)00880304435056(17)210621(10)119740 (01)00880304435056(17)210901(10)144470 (01)00880304435056(17)221029(10)493280 (01)00880304436008(17)210210(10)378130 (01)00880304436008(17)210315(10)630480 (01)00880304436008(17)210830(10)367660 (01)00880304436008(17)210906(10)146740 (01)00880304434448(17)201209(10)650510 (01)00880304434448(17)201228(10)631550 (01)00880304434448(17)210607(10)776080 (01)00880304434448(17)210707(10)429290 (01)00880304434448(17)230221(10)493290 (01)00880304435971(17)250911(10)819130 (01)00880304435971(17)260728(10)094020 (01)00880304434387(17)251211(10)473360 (01)00880304434387(17)261101(10)094010 (01)00880304437500(17)260714(10)802880 (01)00880304437500(17)260720(10)094000
- LOTS
- Amount recalled
- 217240
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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