DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling SpiraLok 6.5 anchors because they may fracture after surgery, requiring patients to undergo revision procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 additional surgery (revision), meeting the criteria for a Severe rating.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson company, is recalling SpiraLok 6.5 anchors without needles with Orthocord (Product Number 222971). 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 is being conducted because the anchors may fracture after the operation, which requires patients to undergo revision surgery. The agency has classified this as a Class II recall. The affected products were distributed worldwide, including in the United States and numerous other countries.
Patients who have had these anchors implanted should contact their healthcare provider to discuss their specific situation and the need for potential revision surgery.
The recalled product
- Product
- SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 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.
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 →- HighCartilage Transplant System Disposable Kits Recalled for Missing Component
FDA (Devices) · 2025-03-19
- HighCOR Disposable Cartilage Transplant Kit recalled for missing graft loader pin
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
- HighDePuy Mitek BIOKNOTLESS Plus Anchor Inserter Tip May Fracture During Surgery
FDA (Devices) · 2023-06-14
Same hazard · device fracture
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- HighHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23
Similar recalls
- HighDePuy Mitek surgical anchor inserter may fracture during use
FDA (Devices) · 2023-06-14
- ModerateDePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling
FDA (Devices) · 2013-05-01
- HighDePuy Mitek surgical anchor inserter tip may fragment and be retained
FDA (Devices) · 2023-06-14
- ModerateDePuy Mitek Recalls Healix Knotless Suture Anchors Due to Material Error
FDA (Devices) · 2019-12-18
- HighSurgical anchor inserter recalled for potential tip fracture and bone damage
FDA (Devices) · 2023-06-14
- ModerateDePuy Mitek Recalls Blue Orthocord Sutures Due to Inaccurate Labeling
FDA (Devices) · 2013-05-01