Reported Dec 4, 2019 · Terminated

HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040…

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?

HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles
CSER Sterile w/ Pin Kit) Item Nos
67 of 67 codes
- HAA60-09030
- HAA60-09040
- HAA60-10030
- HAA60-10040
- HAA60-11030
- HAA60-11040
- HAA60-11050
- HAA60-12040
- HAA60-12060
- HAA60-13030
- HAA60-13040
- HAA60-13050
- HAA60-13060
- HAA60-13070
- HAA60-14050
- HAA60-14080
- HAA60-14090
- HAA60-15020
- HAA60-15030
- HAA60-15040
- HAA60-15050
- HAA60-15060
- HAA60-16030
- HAA60-16040
- HAA60-16050
- HAA60-16070
- HAA60-16090
- HAA60-17040
- HAA60-17060
- HAA60-17080
- HAA60-18010
- HAA60-18030
- HAA60-18040
- HAA60-18050
- HAA60-18060
- HAA60-18090
- HAA60-20030
- HAA60-20040
- HAA60-20050
- HAA60-20060
- HAA60-20080
- HAA60-20090
- HAA60-22050
- HAA60-22060
- HAA60-25030
- HAA60-25040
- HAA60-25050
- HAA60-25060
- HAA60-30060
- HAB60-09030
- HAB60-10030
- HAB60-10040
- HAB60-11040
- HAB60-11050
- HAB60-12040
- HAB60-12060
- HAB60-13040
- HAB60-13050
- HAB60-13060
- HAB60-14050
HAB60-20090 808200000 Product UsageThese devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures

Lot codes and dates: Lots
2,145 of 2,145 codes
089610
241030
089600
241020
238180
416260
507280
450740
314580
736790
779690
889140
836030
970200
444550
984630
316530
198990
419500
431591
444655
459030
633280
921380
148200
441530
718410
884690
856150
444530
066610
352090
553250
HA109-05
148190
666010
825420
989490R
989490
444510
444510R
984610
241410
390410
152390
316520
390410R
432706
484710
484720
238170
427280
450730
323210
507270
748450
789870
877610
002130
444500
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(01)00887868103902(17)221001(10)399770 (01)00887868103902(17)230219(10)516000 (01)00887868103902(17)230319(10)616920 (01)00887868103902(17)230509(10)213440 (01)00887868103902(17)230521(10)276110 (01)00887868103902(17)230528(10)276180 (01)00887868103902(17)230711(10)732650 (01)00887868103902(17)230711(10)732640 (01)00887868103902(17)230807(10)732630 (01)00887868103902(17)231215(10)824070 (01)00887868103902(17)231215(10)824060 (01)00887868103902(17)240209(10)612680 (01)00887868103902(17)240414(10)459790 (01)00887868103902(17)240415(10)459800 (01)00887868103902(17)240602(10)591830 (01)00887868103902(17)240602(10)591780 (01)00887868103902(17)240610(10)591860 (01)00887868103902(17)240611(10)591800 (01)00887868103902(17)240611(10)591810 (01)00887868103902(17)240623(10)949950 (01)00887868103902(17)240805(10)484540 (01)00887868103902(17)240807(10)484520 (01)00887868103902(17)240812(10)484530 (01)00887868103902(17)240817(10)804040 (01)00887868103902(17)240819(10)484510 (01)00887868103902(17)241111(10)785530 (01)00887868103902(17)241112(10)973730 (01)00887868103902(17)241202(10)621760 (01)00887868103902(17)250116(10)099330 (01)00887868103902(17)250213(10)770740 (01)00887868103902(17)250218(10)877440 (01)00887868103902(17)250319(10)133980 (01)00887868103902(17)250324(10)133950 (01)00887868103902(17)250325(10)133960 (01)00887868103902(17)250331(10)133970 (01)00887868103902(17)251207(10)628090 (01)00887868103902(17)251209(10)558800 (01)00887868103902(17)251217(10)941270 (01)00887868103902(17)260119(10)310500 (01)00887868103902(17)260204(10)588250 (01)00887868103902(17)260527(10)186080 (01)00887868103902(17)260527(10)186080R (01)00887868103902(17)260602(10)152320 (01)00887868103902(17)260616(10)252460 (01)00887868103902(17)260617(10)186090 (01)00887868103902(17)260621(10)233920 (01)00887868103902(17)260711(10)571910 (01)00887868103902(17)260714(10)571920 (01)00887868103902(17)270908(10)202720 (01)00887868103902(17)271012(10)199210 (01)00887868103902(17)280302(10)002140 (01)00887868103902(17)280307(10)716940 (01)00887868103902(17)280308(10)716930 (01)00887868103902(17)280308(10)717110 (01)00887868103902(17)280313(10)717120 (01)00887868103902(17)280320(10)002210 (01)00887868103902(17)280320(10)716950 (01)00887868103902(17)280322(10)716960 (01)00887868103902(17)2803
Amount recalled: 178886

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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Other recalls from Zimmer Biomet, Inc.

84 in total.

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