DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 4,151 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.
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 involves a medical device failure (fracture) that has resulted in significant injury requiring revision surgery, meeting the criteria for a Severe (Score 4) classification.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 4,151 units of SpiraLok 6.5 anchors with needles and violet and blue Orthocord (Product Number: 222987). The recall is due to reports of the anchors fracturing after surgery, which has required patients to undergo revision surgery.
These 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. The affected units were distributed worldwide, including the United States and numerous international markets.
Patients who have had these anchors implanted should contact their healthcare provider to discuss their specific situation. The recall covers all lot codes for this specific product number.
The recalled product
- Product
- SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 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
- 4,151
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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