FDA recall Z-1238-2024

Synthes (USA) Products LLC · Class II · device

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

Reason for recall

Products not sterilized, sterility cannot be confirmed

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2024-01-24
Report date
2024-03-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1238-2024