Class 2 Device Recall SpiraLok 5.0 w/Needles with Orthocord

• Date Initiated by Firm: September 06, 2012
• Date Posted: October 25, 2012
• Recall Status: Terminated on June 03, 2015
• Recall Number: Z-0148-2013
• Recall Event ID: 63121
• 510(K)Number: K041069 K060271
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
• Code Information: All lot codes
• Recalling Firm/ Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.; 325 Paramount Drive; Raynham MA 02767-5199
• For Additional Information Contact: 508-880-8100
• Manufacturer Reason for Recall: Fracture of SPIRALOK Anchors post op, requiring patient revision
• FDA Determined Cause: Device Design
• Action: DePuy Mitek sent an Urgent Voluntary Product Recall letter dated September 6, 2012, to all affected customers. Dr Doctor letters were included with the recall letter. Recall is coordinated with Stericycle , contact 1-888-202-3694 The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the enclosed Business Reply Form, even if they have no product remaining in their inventory. Customers were instructed to isolate all inventory of the affected product and return to Stericycle at the following address or fax to 1-888-912-2189 with the completed Business Reply Form: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event #8874 Customers with questions were instructed to call 1-888-202-3694. For questions regarding this recall call 508-880-8100.
• Quantity in Commerce: 7 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.
• 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 = HWC