FDA recall Z-0326-2020

Product

Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 00118101032 00118101035 00118101037 00118101040 00118101042 00118101045 00118101047 00118101050 00118101052 00118101055 00118101057 00118101060 00118101522 00118101525 00118101527 00118101530 00118101532 00118101547 00118101552 00118101557 00118109006 00118109008 00118109010 00118109506 00118109510 00118113002 00118113003 00118113004 00118113005 00118113006 00118113008 00118113010 00118113012 00118113094 00118113502 00118113503 00118113504 00118113505 00118113506 00118113508 00118113510 00118113512 00118113514 00118113594 00118113595 00118114002 00118114003 00118114004 00118114005 00118114006 00118114008 00118114010 00118114012 00118114014 00118114094 00118114095

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-0326-2020