DePuy Charnley Pin Retractor and Handle Set Recalled for Component Breakage
DePuy Orthopaedics is recalling 65 units of the Charnley Pin Retractor and Handle Set because the small extraction peg is breaking from the pin.
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 surgical instrument where a component is breaking, which poses a risk of harm during a procedure. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 65 units of the Charnley PN Retract & Handle (REF 962004000, Non-Sterile). The product is a surgical instrument set used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.
The recall is being conducted because the small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. The affected units are distributed worldwide, including nationwide in the United States and internationally to Australia, Chile, the UK, India, Ireland, Japan, New Zealand, Russia, Singapore, and Saudi Arabia. Specific lot numbers include OSA-149328, OSA-181610, and OSA-161157.
Healthcare facilities and consumers should stop using the affected Charnley Pin Retractor and Handle sets and contact DePuy Orthopaedics for further instructions regarding the recall.
The recalled product
- Product
- Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 65
Distribution
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