Z-1816-2012Class II

Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive...

Name: Z-1816-2012 Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-12-29
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-12-29 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green... on 2011-12-29. FDA classified it as Class II and gives the reason as "Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1816-2012
Classification: Class II
Status: Terminated
Initiated: 2011-12-29
Posted: 2012-06-15
Terminated: 2013-06-13
Recalling firm: 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.
Product code: GAC Rasp, Surgical, General & Plastic Surgery
Reason for recall: Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
Root cause tag: design
FDA 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 in commerce: 41 units
Distribution: Nationwide Distribution
Product codes and lots: 510K exempt Catalog Number 1020-1400 Lot Code P5E93

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1816-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1816-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-15

Product code GAC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)