FDA Enforcement
Class II
Ongoing
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
Recall: Z-1238-2024
·
Reported March 13, 2024
Enforcement
- Recall Number
- Z-1238-2024
- Event ID
- 93924
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 13, 2024
- Initiation Date
- January 24, 2024
- Classification Date
- March 1, 2024
- Address
- 1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States
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
Products not sterilized, sterility cannot be confirmed
Code Info
UDI: 10887587057262 Lot Number: 499P371
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.
Quantity
10 units