FDA recall Z-1058-2018

Zimmer Biomet, Inc. · Class II · device

Product

CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ E-R MINUS¿¿ CR-FLEX GSF PCT SZ F-L MINUS¿ CR-FLEX GSF PCT SZ F-R MINUS¿ CR-FLEX GSF PCT SZ G-L MINUS¿ CR-FLEX GSF PCT SZ G-R MINUS¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Distribution

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

Key facts

Status
Terminated
Initiation date
2017-11-29
Report date
2018-03-21
Termination date
2020-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2018