FDA recall Z-0325-2020

Product

Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531 32855430536 32855430537 32855430538 32855430539 32855430541 32855430543 32855430546 32855430548 32855430549 32855430550 32855430551 32855430556 32855430557 32855430558 32855430563 32855430565 32855430567 32855430568 32855430569 32855430570 32855430574 32855430575 32855430577 32855450420 32855450441 32855450453 32855450461 32855450499 32855470626 32855470639 32855470641 32855470644 32855470645 32855470648 32855470649 32855470652 32855470653 32855470654 32855470660 32855470663 32855470666 32855470667 32855470669 32855470672 32855470673 32855470679 32855470680 32855470682 32855470683 32855470684 32855470686 32855470688 32855470689 32855470692 32855470693 328554

Reason for recall

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

Distribution

Distributed nationwide.

Key facts

Status

Terminated

Initiation date

2019-10-10

Report date

2019-11-13

Termination date

2020-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0325-2020