PlainRecalls
FDA Devices Moderate Class II Terminated

Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 0

Reported: November 13, 2019 Initiated: October 10, 2019 #Z-0323-2020

Product Description

Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 00585205009 00585205010 00585205011 00585205012 00585205013 00585205014 00585205015 00585205016 00585205017 00585205018 00585205019 00585205209 00585205210 00585205211 00585205212 00585205213 00585205214 00585205215 00585205216 00585205217 00585205218 00585205219 00585205412 00585205413 00585205414 00585205415 00585205416 00585205417 00585205418 00585205419 00585207009 00585207010 00585207011 00585207012 00585207013 00585207014 00585207015 00585207016 00585207017 00585207018 00585207019 00585207409 00585207410 00585207411 00585207412 00585207413 00585207414 00585207415 00585207416 00585207417 00585207418 00585207419 500000001 500000005 500000010 500010000 502000001 502006006 502006011

Reason for Recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
5,459,583 total devices
Distribution
Distributed nationwide.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 00585205009 00585205010 00585205011 00585205012 00585205013 00585205014 00585205015 00585205016 00585205017 00585205018 00585205019 00585205209 00585205210 00585205211 00585205212 00585205213 00585205214 00585205215 00585205216 00585205217 00585205218 00585205219 00585205412 00585205413 00585205414 00585205415 00585205416 00585205417 00585205418 00585205419 00585207009 00585207010 00585207011 00585207012 00585207013 00585207014 00585207015 00585207016 00585207017 00585207018 00585207019 00585207409 00585207410 00585207411 00585207412 00585207413 00585207414 00585207415 00585207416 00585207417 00585207418 00585207419 500000001 500000005 500000010 500010000 502000001 502006006 502006011. Recalled by Zimmer Biomet, Inc.. Units affected: 5,459,583 total devices.
Why was this product recalled?
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Which agency issued this recall?
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0323-2020.