Stryker Howmedica Command Instrument Broach Handle Recalled for Fracture Risk
Stryker Howmedica is recalling 48 Command Instrument Broach Handles used in hip surgery due to reports of handle fracture and component disassociation.
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 high-risk medical device where a mechanical failure (fracture) poses a risk of harm during surgery, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 48 units of the Command Instrument Broach Handle, Catalog Number 6266-0-100. This medical device is used in Total Hip Arthroplasty procedures. The recall covers specific lot codes including RD6W017, RD7L234X, and others listed in the agency documentation.
The recall was initiated due to reports of handle fracture and the subsequent disassociation of cam assembly subcomponents during use. The affected units were distributed nationwide.
Healthcare providers and facilities should stop using the affected Command Instrument Broach Handles immediately. Users should contact Stryker Howmedica Osteonics Corp. for instructions on returning the devices or obtaining replacements.
The recalled product
- Product
- Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 48
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 (14)
- Catalog Number: 6266-0-100 Lot Code: RD6W017
- RD7L234X
- RD7L234
- RD7L235
- RD5T305A
- RD6W017J
- RD6W017A
- RD5T307
- RD5T305T
- RD5T305M
- RD5T305L
- RD5T306X
- RD5T305
- RD5T306
Distribution
Distributed nationwide across the United States.
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