Stryker Accolade Offset Rasp Handle Recalled for Potential Fracture
Stryker Howmedica Osteonics is recalling 41 Accolade Offset Rasp Handles due to a potential risk of fracturing during use in total hip arthroplasty.
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 medical device with a risk of fracture during use, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 41 units of the Accolade Offset Rasp Handle. This medical device is a single offset rasp handle designed to mate with Accolade femoral broaches to prepare the femoral canal during total hip arthroplasty using the Accolade Hip System.
The recall was initiated because Stryker Orthopaedics became aware of the potential for the Accolade Rasp Handle Assembly to fracture upon use. The product is identified by Catalog Number 1020-1400 and Lot Code P5E93. The units were distributed nationwide.
Healthcare providers and facilities should stop using the affected devices and contact Stryker Howmedica Osteonics Corp. for further instructions on the recall.
The recalled product
- Product
- Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 41
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 510K exempt Catalog Number 1020-1400 Lot Code P5E93
Distribution
Distributed nationwide across the United States.
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