FDA recall Z-0312-2020

Product

Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813 47492800902 47492800907 47492801002 47492801007 47492801013 47492801207 47492801213 47492801413 47492801607 47492801613 47492801702 47492801802 47492801813 47492801902 47492802002 47492802013 47493600313 47493600403 47493600407 47493600413 47493600503 47493600507 47493600513 47493600603 47493600607 47493600613 47493600703 47493600707 47493600713 47493600803 47493600807 47493600813 47493600907 47493600913 47493601003 47493601007 47493601013 47493601113 47493601203 47493601207 47493601213 47493601313 47493601403 47493601407 47493601413 47493601513 47493601607 47493601613 47493601813 47493602007 47493602013 47493602213 47493603305 47493603306 47493603405 47493

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-0312-2020