FDA recall Z-1044-2018

Zimmer Biomet, Inc. · Class II · device

Product

LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E-R LPS-FLEX PRECOAT FEMORAL F-L LPS-FLEX PRECOAT FEMORAL F-R LPS-FLEX PRECOAT FEMORAL G-L LPS-FLEX PRECOAT FEMORAL G-R LPS-FLEX PRECOAT FEMORAL H-L LPS-FLEX PRECOAT FEMORAL H-R¿ LPS-FLEX POROUS FEMORAL E-R This device is indicated for patients with severe knee pain and disability¿

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-1044-2018