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Terminated

Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

FDA Recall Z-2557-2011 · Posted 2011-06-13

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeISL
Date Initiated2011-03-01
Date Terminated2012-10-10
Product Quantitytotal of all units is 44

Reason for Recall

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

Firm Action

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

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032300ACCOLADE-J HIP STEM SERIESHowmedica Osteonics Corp. · 2003-10-09K994366TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEMHowmedica Osteonics Corp. · 2000-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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