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DePuy Mitek, Inc., a Johnson & Johnson Co. recalls SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used
Recalled October 31, 2012 · FDA recall Z-0153-2013 · DePuy Mitek, Inc., a Johnson & Johnson
Hazard
Fracture of SPIRALOK Anchors post op, requiring patient revision · FDA Class II
Units
39,362 units
Sold at
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.
Description
Fracture of SPIRALOK Anchors post op, requiring patient revision
Product
SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 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
Manufacturer(s)
DePuy Mitek, Inc., a Johnson & Johnson Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →