DePuy Mitek Recalls Seven SpiraLok 6.5 Anchors Due to Fracture Risk
DePuy Mitek is recalling seven SpiraLok 6.5 anchors because they fractured 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 resulted in significant injury requiring revision surgery, meeting the criteria for a Severe rating.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson company, is recalling seven units of SpiraLok 6.5 anchors with needles and Orthocord (Product Number 222970). 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 fractured post-operatively, which required patients to undergo revision surgery. The recall covers all lot codes for this specific product number.
The affected units were distributed worldwide, including the United States and numerous international markets. Patients who have had these specific anchors implanted should contact their healthcare provider to discuss the recall and potential need for evaluation.
The recalled product
- Product
- SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 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.
- Hazard
- Affected units
- 7
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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