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
Reported: October 31, 2012 Initiated: September 6, 2012 #Z-0148-2013
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
Details
- Recalling Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Units Affected
- 7 units
- Distribution
- 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.
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co.. Units affected: 7 units.
Why was this product recalled? ▼
Fracture of SPIRALOK Anchors post op, requiring patient revision
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2012. Severity: Moderate. Recall number: Z-0148-2013.
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