The Recall Desk
HighFDA (Devices)·Z-1816-2012·Announced 2012-06-27

Stryker Accolade Offset Rasp Handle Recalled for Potential Fracture

Stryker Howmedica Osteonics is recalling 41 Accolade Offset Rasp Handles due to a potential risk of fracturing during use in total hip arthroplasty.

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 medical device with a risk of fracture during use, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling 41 units of the Accolade Offset Rasp Handle. This medical device is a single offset rasp handle designed to mate with Accolade femoral broaches to prepare the femoral canal during total hip arthroplasty using the Accolade Hip System.

The recall was initiated because Stryker Orthopaedics became aware of the potential for the Accolade Rasp Handle Assembly to fracture upon use. The product is identified by Catalog Number 1020-1400 and Lot Code P5E93. The units were distributed nationwide.

Healthcare providers and facilities should stop using the affected devices and contact Stryker Howmedica Osteonics Corp. for further instructions on the recall.

The recalled product

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 femo
Affected units
41

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 (1)

  • 510K exempt Catalog Number 1020-1400 Lot Code P5E93

Distribution

Distributed nationwide across the United States.