FDA Recall Terminated

Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker Howmedica Osteonics, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 The Xcelerate patella milling system (as detailed in surgical protocol LSPK35) was designed to prepare a patella to accept all Scorpio or Duracon patellar implants using either a resurfacing or recessed technique.

Recall: Z-1862-2011 · Initiated January 27, 2011

Recall

Recall Number: Z-1862-2011
Event Number: 57852
Firm: Stryker Howmedica Osteonics Corp.
FEI Number: 3003070421
Product Code: HTJ
Status: Terminated
Root Cause: Device Design
Initiated: January 27, 2011
Posted: March 31, 2011
Terminated: October 15, 2012
Address: 325 Corporate Drive, Mahwah, NJ, 07430

Description

Reason

Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone.

Action

Stryker sent an Urgent Product Recall letter dated January 27, 2011, via FedEX for January 28, 2011, delivery with return receipt. The letter identified the product, the problem, and the action to be taken by the customer. Customers were insructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069. Customers were also instructed to contact the hospitals in their territory that have the affected product to arrange return of the product. Product should be returned to the attention of: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey, 07430. The orange Product Remediation sticker should be attached to the return, indicating the Product Remediation # RA 2009-296. Mark the outer box with words "Product Recall." For questions regarding this recall call (201) 972-2100.

Distribution

Nationwide Distribution

Quantity

52 units