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U.S. Department of Health and Human Services

Class 2 Device Recall SpiraLok 5.0mm with Ethibond without needles

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  Class 2 Device Recall SpiraLok 5.0mm with Ethibond without needles see related information
Date Initiated by Firm September 06, 2012
Date Posted October 25, 2012
Recall Status1 Terminated 3 on June 03, 2015
Recall Number Z-0144-2013
Recall Event ID 63121
510(K)Number K041069  K060271  
Product Classification Screw, fixation, bone - Product Code HWC
Product SpiraLok 5.0mm with Ethibond without needles
Product Number: 222964

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 2		 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 400 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 and Original Applicant = DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
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