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
Reported: March 13, 2024 Initiated: January 24, 2024 #Z-1238-2024
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
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 10 units
- 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.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Synthes (USA) Products LLC. Units affected: 10 units.
Why was this product recalled? ▼
Products not sterilized, sterility cannot be confirmed
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2024. Severity: Moderate. Recall number: Z-1238-2024.
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