FDA-Device2012-10-31Class II
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
DePuy Mitek, Inc., a Johnson & Johnson Co.
Hazard
Fracture of SPIRALOK Anchors post op, requiring patient revision
Sold states
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.
Affected count
39,362 units
Manufactured in
325 Paramount Drive, N/A, Raynham, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0153-2013Don't want to check this manually?
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