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.
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 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.
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