Z-1238-2024 Class II Ongoing
FDA device recall Z-1238-2024 was initiated by Synthes (USA) Products LLC on January 24, 2024 and is designated Class II. Reason for recall: Products not sterilized, sterility cannot be confirmed The recall status is ongoing. Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2024
- Initiation Date
- January 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
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
Reason for Recall
Products not sterilized, sterility cannot be confirmed
Distribution Pattern
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.
Code Information
UDI: 10887587057262 Lot Number: 499P371