Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 C

FDA device recall Z-2557-2011 · posted 2011-06-13 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole.

Action taken

Stryker Orthopaedics sent an Urgent Product Recall letter dated March 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed 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. Return the affected product via and Inter-Org Transfer to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey 07430. Attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation # RA 2009-459. Mark the outer box with the words "Product Recall." For any questions call (201) 972-2100.

Root cause

Employee error

Status

Terminated

Product code

ISL

Quantity affected

total of all units is 44

Distribution

Nationwide Distribution

Date initiated

2011-03-01

Date posted

2011-06-13

Date terminated

2012-10-10

Location

Mahwah, NJ

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