Reported Dec 4, 2019 · Terminated

GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems…

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?

- GUIDE WIRE 2.2MM X 28IN
- Aim/Art Guide wire
- Item No. 809222028 -
Product UsageThese instruments and delivery systems are used to facilitate implantation of orthopedic medical devices

Lot codes and dates: Lots
139 of 139 codes
323740
323770
323870
323970
324050
957830
957880
323840
323890
323910
323930
957800
987260
987480
987720
485140
486100
485470
485850
069570
069980
070100
977580
977670
977690
977700
977710
977720
977730
977750
661460
661440
661450
161370
166860
166870
166870R
108410
108350
108380
108390
108400
108430
108450
472150
392630
392650
392660
392680
233870
233900
471850
471860
471870
472140
472160
036430
036390
036370
036360
ZJ2AA7000 ZJ5AA7000 ZJ5AAA UDI(01)00887868034664(17)240619(10)323970 (01)00887868034664(17)240619(10)324050 (01)00887868034664(17)240708(10)957800 (01)00887868034664(17)240716(10)987260 (01)00887868034664(17)240717(10)987480 (01)00887868034664(17)240717(10)987720 (01)00887868034664(17)240828(10)485140 (01)00887868034664(17)240828(10)486100 (01)00887868034664(17)240829(10)485470 (01)00887868034664(17)240902(10)485850 (01)00887868034664(17)241015(10)069570 (01)00887868034664(17)241016(10)069980 (01)00887868034664(17)241017(10)070100 (01)00887868034664(17)250121(10)977580 (01)00887868034664(17)250122(10)977670 (01)00887868034664(17)250122(10)977690 (01)00887868034664(17)250122(10)977700 (01)00887868034664(17)250122(10)977710 (01)00887868034664(17)250122(10)977720 (01)00887868034664(17)250122(10)977730 (01)00887868034664(17)250122(10)977750 (01)00887868034664(17)250408(10)661460 (01)00887868034664(17)250408(10)661440 (01)00887868034664(17)250408(10)661450 (01)00887868034664(17)250601(10)161370 (01)00887868034664(17)250630(10)166860 (01)00887868034664(17)250601(10)166870 (01)00887868034664(17)250601(10)166870R (01)00887868034664(17)250902(10)108410 (01)00887868034664(17)250902(10)108350 (01)00887868034664(17)250902(10)108380 (01)00887868034664(17)250902(10)108390 (01)00887868034664(17)250902(10)108400 (01)00887868034664(17)250903(10)108430 (01)00887868034664(17)250903(10)108450 (01)00887868034664(17)260610(10)472150 (01)00887868034664(17)260630(10)392630 (01)00887868034664(17)260111(10)392650 (01)00887868034664(17)260111(10)392660 (01)00887868034664(17)260111(10)392680 (01)00887868034664(17)260111(10)233870 (01)00887868034664(17)260111(10)233900 (01)00887868034664(17)260616(10)471850 (01)00887868034664(17)260111(10)471860 (01)00887868034664(17)260610(10)471870 (01)00887868034664(17)260616(10)472140 (01)00887868034664(17)260623(10)472160 (01)00887868034664(17)260614(10)036430 (01)00887868034664(17)260616(10)036390 (01)00887868034664(17)260623(10)036370 (01)00887868034664(17)260624(10)036360 (01)00887868034664(17)260624(10)036400 (01)00887868034664(17)260624(10)036450 (01)00887868034664(17)260628(10)036380 (01)00887868034664(17)260628(10)036410 (01)00887868034664(17)260628(10)036420 (01)00887868034664(17)260628(10)036440 (01)00887868034664(17)260628(10)036460
Amount recalled: 2468

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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By hazard

Medical device recalls

Other recalls from Zimmer Biomet, Inc.

84 in total.

All recall categories · Browse the whole archive