Z-0148-2013 Class II Terminated
FDA device recall Z-0148-2013 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Sep 6, 2012 and is designated Class II. Reason for recall: Fracture of SPIRALOK Anchors post op, requiring patient revision The recall status is terminated (terminated Jun 3, 2015). Affected quantity: 7 units.
Recall details
- Product Type
- Devices
- Report Date
- Oct 31, 2012
- Initiation Date
- Sep 6, 2012
- Termination Date
- Jun 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product description
SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 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
Reason for recall
Fracture of SPIRALOK Anchors post op, requiring patient revision
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.
Code information
All lot codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0148-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026