Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker Howmedica Os

FDA device recall Z-1862-2011 · posted 2011-03-31 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

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 taken

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.

Root cause

Device Design

Status

Terminated

Product code

HTJ

Quantity affected

52 units

Distribution

Nationwide Distribution

Date initiated

2011-01-27

Date posted

2011-03-31

Date terminated

2012-10-15

Location

Mahwah, NJ