FDA (Devices) recall action 83783

Zimmer Biomet, Inc. recalled 15 products on 2019-12-04

The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products: 15
Announced: 2019-12-04
Critical: 0
Units: 2,597,664

Why these products were recalled

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–15 of 15

HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Custom Medical Devices Due to Cleaning Issues
Zimmer Biomet is recalling various custom medical devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.
Product
Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 CP113778 CP113782 CP113783 CP114083 CP114090 CP114112 CP114118 CP114148 CP114
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0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Ball Nose Guide Wires Due to Cleaning Issues
Zimmer Biomet is recalling Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Category
Distribution
0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Copeland HA Resurfacing Heads Due to Cleaning Issues
Zimmer Biomet is recalling Copeland HA Resurfacing Heads because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Pr
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0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris
Zimmer Biomet is recalling 2.0mm Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Category
Distribution
0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls HA Pins and Hoffman/Colles Pins Due to Cleaning Issues
Zimmer Biomet is recalling HA Pins and Hoffman/Colles Pins because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: 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 HAA
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0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Hip Systems Due to Cleaning Issues
Zimmer Biomet is recalling various hip arthroplasty systems because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-10
Category
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0 states
SevereFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Acromium Flange Sets Due to Cleaning Issues
Zimmer Biomet is recalling Acromium Flange Sets because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Category
Distribution
0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris
Zimmer Biomet is recalling specific Aim/Art Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Category
Distribution
0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Hennessy Left Constrained Glenoid Shoulder Implants
Zimmer Biomet is recalling Hennessy Left Constrained Glenoid Humeral Shoulder Implants due to elevated bacterial endotoxin and residual debris caused by a cleaning issue.
Product
HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
Category
Distribution
0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Shoulder Baseplates Due to Cleaning Issues
Zimmer Biomet is recalling COMP RVRS Shoulder Baseplates because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 PM555406 PM555415 UDI: (01)00880304475342(17)211128(10
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0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Compress Mini Compress Devices Due to Cleaning Issues
Zimmer Biomet is recalling Compress Mini Compress devices because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 17857
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0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Custom Shoulder Implants Due to Cleaning Issues
Zimmer Biomet is recalling specific custom shoulder replacement implants because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
Category
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0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Comprehensive RS Cleat CAP Due to Contamination
Zimmer Biomet is recalling Comprehensive RS Cleat CAP devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.
Product
Comprehensive RS Cleat CAP, Item No. 110300
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Distribution
0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls Total Elbow Replacement Devices Due to Cleaning Issues
Zimmer Biomet is recalling specific total elbow replacement devices because elevated levels of bacterial endotoxin and residual debris remain on them due to a cleaning issue.
Product
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. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 11475
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0 states
HighFDA (Devices)··2019-12-04
Zimmer Biomet Recalls HHR Tess Cleats Due to Bacterial Endotoxin
Zimmer Biomet is recalling Comprehensive HHR Tess Cleats because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
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0 states