FDA recall Z-0321-2020

Product

Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008000 00522400800 00522400900 00522406201 00541001401 00541001501 00541001502 00541001601 00541001602 00541001701 00541001702 00541001801 00541001802 00541201501 00541201502 00541201601 00541201602 00541201701 00541201702 00541201801 00541201802 00541401301 00541401302 00541401401 00541401402 00541401501 00541401502 00541401601 00541401602 00541401701 00541401702 00541601401 00541601402 00541601501 00541601502 00541601601 00541601602 00575001301 00575001302 00575001305 00575001306 00575001401 00575001402 00575001405 00575001406 00575001501 00575001502 00575001505 00575001506 00575001601 00575001602 00575001605 00575001606 00575001701 00575001702 00575001705

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-0321-2020