DePuy Specialist 2 IM Rod Recalled for Potential Breakage Risk
DePuy Orthopaedics is recalling Specialist 2 IM Rods and associated surgical techniques due to a potential risk of the rod breaking and leaving fragments in patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (breakage) that could leave fragments in a patient, meeting the criteria for a Severe rating (score 4) due to the potential for significant injury.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the Specialist 2 IM Rod, Non-Sterile, and associated surgical techniques. The recall involves the Sigma HP Instruments Classic, Balanced, and Fixed Reference Surgical Techniques, as well as PFC Sigma Knee Systems primary procedure techniques. The product is used in primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block, and is included in SP2 and HP instrument kits.
The recall is being conducted because of a potential for the intramedullary (IM) rod to break, which could leave fragments in the patient. The company has updated the surgical techniques guidance to reduce the likelihood of potential failure until design changes can be made to the product.
Approximately 4,000 units were distributed worldwide, with 2,600 units distributed in the United States. The products were distributed nationwide in the USA. Healthcare providers should contact DePuy Orthopaedics for further instructions on how to manage the recalled devices and updated surgical techniques.
The recalled product
- Product
- Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee…
- Manufacturer
- DePuy Orthopaedics, Inc.
Distribution
Distributed nationwide across the United States.
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