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
FDA Recall Z-0148-2013 · Posted 2012-10-25
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Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
Recall StatusTerminated
Product CodeHWC
Date Initiated2012-09-06
Date Terminated2015-06-03
Product Quantity7 units
Reason for Recall
Fracture of SPIRALOK Anchors post op, requiring patient revision
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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