Synthes Slipped Capital Femoral Epiphysis System Recalled for Drill Bit Breakage
Synthes USA is recalling 166 units of the Slipped Capital Femoral Epiphysis System because guide wires may stick and drill bits may break during surgery.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed adverse events.
Plain-English summary
Synthes USA HQ, Inc. is recalling 166 units of the Slipped Capital Femoral Epiphysis System. The system is intended for fracture fixation of large bones and large bone fragments, as well as for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures, and sacroiliac joint disruptions.
The recall is due to a possibility that the Guide Wires of the system may stick in the cannulation of the drill bit, and that the drill bits may break during surgery. The affected products are Parts 03.207.001 and 03.207.008 with specific lot numbers listed in the agency record. The products were distributed nationwide in the United States.
Healthcare providers and facilities that have received these products should stop using them and contact Synthes USA HQ, Inc. for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 166
Distribution
Distributed nationwide across the United States.
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