FDAClass IIJune 27, 2012

Stryker Howmedica Osteonics Accolade Offset Rasp Handle recall

Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas…

Why was Stryker Howmedica Osteonics Accolade Offset Rasp Handle recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

510K exempt Catalog Number 1020-1400 Lot Code P5E93

Product
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas…
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
41 units
Distribution
Nationwide Distribution
Recall date
June 27, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls