FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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 femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.
- Recall number
- Z-1816-2012
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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 femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.
- Status
- Terminated
- Initiated
- 2011-12-29
- Posted
- 2012-06-15
- Terminated
- 2013-06-13
- Reason
- Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
- Root cause
- Device Design
- Action
- Stryker Orthopaedics sent an email notification to all consignees on December 29, 2011, which was followed by an Urgent Product Recall letter dated January 4, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the attached Product Recall Acknowledgement Form and fax back to 201-831-8089 within 5 days. Customers were also asked to contact the hospitals in their territory that have the affected product to arrange return of the product. Customers were instructed to return the affected product to the attention of Regulatory Compliance, Stryker Orthopedics, 325 Corporate Drive, Mahwah, New Jersey 07430 with the fluorescent orange PRODUCT REMEDIATION sticker attached indicating the Product Remediation # RA 2011-161. Mark the outer box with the words "Product Recall." For questions customers were instructed to call 201-972-2100. For questions regarding this recall call 201-831-5970.
- Quantity
- 41 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 510K exempt Catalog Number 1020-1400 Lot Code P5E93
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAC
- 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