Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2012 - (Recall #: Z-1816-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 29, 2011

Date Posted: June 27, 2012

Recall Number: Z-1816-2012

Event ID: 62130

Reason for Recall:

Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.

Status: Terminated

Product Quantity: 41 units

Code Information:

510K exempt Catalog Number 1020-1400 Lot Code P5E93

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated