FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
- Recall number
- Z-0919-2013
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
- Status
- Terminated
- Initiated
- 2012-12-20
- Posted
- 2013-03-08
- Terminated
- 2015-09-30
- Reason
- Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
- Root cause
- Process control
- Action
- Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue.
- Quantity
- 48 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28