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U.S. Department of Health and Human Services

Class 2 Device Recall SpiraLok 5.0 w/Needles with Orthocord

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 Class 2 Recall
SpiraLok 5.0 w/Needles with Orthocord
see related information
Date Posted October 25, 2012
Recall Status1 Open
Recall Number Z-0148-2013
Recall Event ID 63121
Premarket Notification
510(K) Numbers
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, Massachusetts 02767-5199
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Fracture of SPIRALOK Anchors post op, requiring patient revision
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
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