DePuy RECLAIM Hip Implant Inserter Adaptor Recalled for Fracture Risk
DePuy Orthopaedics is recalling 54 units of the RECLAIM Assembled Implant Inserter Adaptor because the instrument may fracture during surgery, potentially leaving plastic pieces in the patient.
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 surgical instrument that may fracture and leave foreign material (plastic pieces) in a patient, which constitutes a significant injury risk.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 54 units of the RECLAIM Assembled Implant Inserter Adaptor, an orthopedic manual surgical instrument used for hip implantation. The recall involves Lot No. SO2018074, Catalog No. 2975-00-920, and Barcode (GTIN) 10603295156192. Other lots (SO2018072, SO2018073, SO2018075, and SO2018080) were not distributed and are not part of this recall.
The recall is being issued because the instrument may fracture during surgery. If this occurs, there is a potential for plastic pieces to be left in the patient. The agency has classified this as a Class II recall.
The affected units were distributed worldwide, including nationwide in the United States (specifically California), Ireland, and Israel. Healthcare facilities and distributors should stop using the affected instruments and contact DePuy Orthopaedics for instructions on return or replacement.
The recalled product
- Product
- RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
Distribution
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