Device product
SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 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
Z-0152-2013
Product summary
- Event
- Event 63121
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,393 units
- Official record key
device-enforcement:Z-0152-2013
Official wording
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision
Code information: All lot codes
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.
Derived failure modes
-
Unknown
Fracture of SPIRALOK Anchors post op, requiring patient revision