FDA-Device2024-03-13Class II
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
Hazard
Products not sterilized, sterility cannot be confirmed
Sold states
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.
Affected count
10 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1238-2024More Synthes (USA) Products LLC recalls
- FDA-Device2026-04-08Synthes VOLT Locking Screw Tap recalled for incorrect thread due to packaging mix-up
- FDA-Device2026-04-08Synthes 2.4 VOLT Cortex Screw recalled for incorrect thread due to lot swap
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