DePuy Orthopaedics Recalls Specialist 2 Distal Femoral Cutting Blocks
DePuy Orthopaedics is recalling 140 Specialist 2 Distal Femoral Cutting Blocks because they will not connect to the required outrigger, rendering them unusable in 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional defect that renders the device unusable, with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 140 units of the Specialist 2 Distal Femoral Cutting Block (Part code 966115). The recall was initiated because the device will not connect to the Specialist 2 Locating Outrigger, which renders the cutting blocks unusable in surgery.
The affected lots are SO2040929, SO2040602, and SO2037408. The source text notes that Lot SO2037408 was not distributed in the US and was for overseas distribution only. The remaining units were distributed domestically to Iowa, Massachusetts, New York, Ohio, and Pennsylvania, and internationally to Canada, China, Hungary, the United Kingdom, and Singapore. An updated notice expanded the international distribution list to include Belgium, France, Germany, Maldives, New Zealand, and the United Arab Emirates.
Healthcare facilities and distributors should stop using the affected cutting blocks and contact DePuy Orthopaedics for instructions on returning or replacing the devices.
The recalled product
- Product
- SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 140
Distribution
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