DePuy Mitek, Inc., a Johnson & Johnson Co.: Medical Device Recall in 2012 - (Recall #: Z-0142-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 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

Product Classification:

Class II

Date Initiated: September 6, 2012

Date Posted: October 31, 2012

Recall Number: Z-0142-2013

Event ID: 63121

Reason for Recall:

Fracture of SPIRALOK Anchors post op, requiring patient revision

Status: Terminated

Product Quantity: 314 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated