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Recall Observatory FDA recall evidence

Device product

SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 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-0141-2013

September 06, 2012

Class II

Product summary

Firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Event
Event 63121
Status
Terminated
Classification
Class II
Quantity
2560 units
Official record key
device-enforcement:Z-0141-2013

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

    reason.no_named_rule · v1.0.0

    Fracture of SPIRALOK Anchors post op, requiring patient revision