DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 2,560 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fracture) that requires revision surgery, meeting the criteria for a Severe rating.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson company, is recalling 2,560 units of SpiraLok 5.0mm anchors with Panacryl and needles (Product Number: 222961). These medical devices 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.
The recall was initiated because the anchors may fracture after the operation, which requires the patient to undergo revision surgery. The source text does not specify the number of patients affected or report any specific injuries or deaths.
The recalled products were distributed worldwide, including nationwide in the United States and in numerous other countries. The recall applies to all lot codes. Healthcare providers and patients should contact DePuy Mitek for instructions on how to manage the recalled devices.
The recalled product
- 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
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Affected units
- 2,560
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
Same manufacturer · DePuy Mitek, Inc., a Johnson & Johnson Co.
See all →- HighCOR Disposable Cartilage Transplant Kit recalled for missing graft loader pin
FDA (Devices) · 2025-03-19
- HighCartilage Transplant System Disposable Kits Recalled for Missing Component
FDA (Devices) · 2025-03-19
- HighSurgical Anchor Inserter Tip Fragmentation During Patient Procedures
FDA (Devices) · 2023-06-14
- HighDePuy Mitek surgical anchor inserter may fracture during use
FDA (Devices) · 2023-06-14
- HighSurgical anchor inserter recalled for potential tip fracture and bone damage
FDA (Devices) · 2023-06-14
Same hazard · device fracture
See all →- HighSurgify Halo surgical burr recalled for potential breakage during spinal surgery
FDA (Devices) · 2026-07-01
- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- SevereBeacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
- HighVASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System C-Ring Break
FDA (Devices) · 2025-04-30
- HighStryker ACM Bone Cement Mixer Nozzle May Break During Surgery
FDA (Devices) · 2023-09-27