Synthes (USA) Products LLC recalls RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures o

Recalled March 13, 2024 · FDA recall Z-1238-2024 · Synthes (USA) Products

Hazard

Products not sterilized, sterility cannot be confirmed · FDA Class II

Units

10 units

Sold at

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.

Description

Products not sterilized, sterility cannot be confirmed

Product

RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S

Manufacturer(s)

Synthes (USA) Products LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →