Stryker Accolade Broach Handle Recalled Due to Impaction Plate Fracture
Stryker Howmedica Osteonics Corp. is recalling 211 units of the Navigation Compatible Accolade Broach Handle because the impaction plate may dissociate or fracture from the main body.
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 the source describes a structural defect (fracturing/dissociating) in a medical device, which aligns with the 'Severe' criteria for structural defects or significant injury risks.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 211 units of the Stryker Orthopaedics Navigation Compatible Accolade Broach Handle (Catalog no. 2124-1400). The recall affects all lots of the product, which is non-sterile and made in the USA.
The recall was initiated after Stryker received field reports that the impaction plate was dissociating or fracturing from the main body of the broach handle. The affected units were distributed to Illinois, Massachusetts, Minnesota, North Dakota, Oregon, and Pennsylvania.
Healthcare professionals should stop using the affected broach handles and contact Stryker Howmedica Osteonics Corp. for instructions on returning the product.
The recalled product
- Product
- Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 211
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)
- Catalog no. 2124-1400 All lots
Distribution
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