Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. Due to Fracture of SPIRALOK Anchors post op, requiring patient...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Mitek, Inc., a Johnson & Johnson Co. directly.
Affected Products
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
Quantity: 2560 units
Why Was This Recalled?
Fracture of SPIRALOK Anchors post op, requiring patient revision
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek, Inc., a Johnson & Johnson Co. has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report