RAPIDSORB IPS Battery Pack recalled due to unconfirmed sterility
Synthes is recalling 10 units of RAPIDSORB IPS Battery Pack Sterile because the products cannot be confirmed as sterile. The affected lot was distributed worldwide to medical facilities. Patients should consult their healthcare provider about replacement options.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for non-sterile surgical implant with no reported illnesses or injuries. The hazard is theoretical—potential infection risk from implant sterility failure—but actual harm has not been documented. This fits the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes (USA) Products LLC has recalled 10 units of RAPIDSORB IPS Battery Pack Sterile (Part Number: 530.553.01S, Lot Number: 499P371). These devices are intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult patients. The FDA recall was issued because the products were not sterilized and sterility cannot be confirmed.
The affected lot was distributed worldwide, including to the United States and the following countries: Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, and South Africa.
Patients who have or may have received this device should contact their healthcare provider. Healthcare facilities that have received this lot should discontinue use and contact Synthes for guidance on replacement or return procedures.
The recalled product
- Product
- 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
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 10887587057262 Lot Number: 499P371
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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