Medical Device Recall: 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
Synthes (USA) Products LLC · January 24, 2024
Reason for Recall
Products not sterilized, sterility cannot be confirmed
Product Description
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
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.
States Affected
NATIONWIDE
Quantity Affected
10 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1238-2024
Status: ongoing
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