Class 2 Device Recall Accolade TMZF Plus Hip Stem

• Date Initiated by Firm: March 01, 2011
• Date Posted: June 13, 2011
• Recall Status: Terminated on October 10, 2012
• Recall Number: Z-2557-2011
• Recall Event ID: 58455
• 510(K)Number: K032300 K994366
• Product Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code ISL
• Product: 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.
• Code Information: Catalog @ 3020-0537 Accolated TMZF Hip Stem # 5 Lot #31390203 8 units CAtalog #6020-3535 Accolade 132 Size 3.5 Lot #31446602R 0 units CAtalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Lot #31515703 10 units Catalog # 6021-0335 Accolade Plus TMZF Hipe Stem #3 Lot 31586402 10 units Catalog #3021-0435 Accolade TMZF Hipe STem #4 31597205 1 unit CAtalog # 6021-0435 Accolade Plus TMZF Hipe STem #4 Lot #31597206 4 units Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Lot #31486505 10 units Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 Lot #31850001 1 unit
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: Colleen O'Meara; 201-831-5970
• Manufacturer Reason for Recall: Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole.
• FDA Determined Cause: Employee error
• 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.
• Quantity in Commerce: total of all units is 44
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ISL