The Recall Desk
SevereFDA (Devices)·Z-0145-2013·Announced 2012-10-31

SpiraLok 5.0mm Anchors Recalled for Post-Operative Fracture Risk

DePuy Mitek is recalling 232 units of SpiraLok 5.0mm anchors due to post-operative fractures requiring patient revision surgery.

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 invasive revision surgery, meeting the criteria for a Severe rating.

Plain-English summary

DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 232 units of SpiraLok 5.0mm with Panacryl without needles (Product Number: 222965). 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 have fractured post-operatively, a defect that requires patients to undergo revision surgery. The source text does not specify the number of patients affected or the specific dates of the incidents.

The recalled 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 the potential need for revision surgery.

The recalled product

Product
SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 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.
Category
Medical Device — Orthopedic Anchors
Hazard
Affected units
232

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.

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Same hazard · fracture

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