DePuy Mitek Recalls SpiraLok 5.0mm Anchors Due to Fracture Risk
DePuy Mitek is recalling 400 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring revision.
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 400 units of SpiraLok 5.0mm anchors with Ethibond without needles (Product Number 222964). The recall is due to reports of the anchors fracturing after surgery, which has required patients to undergo revision surgery.
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 covers all lot codes for this specific product number.
The affected units were distributed worldwide, including the United States and numerous other countries. Healthcare providers and patients who have used these specific anchors should contact DePuy Mitek or their healthcare provider for further instructions.
The recalled product
- Product
- SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 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
- 400
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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