The Recall Desk
HighFDA (Devices)·Z-0919-2013·Announced 2013-03-20

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.

What this means for you

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
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.