Agency classClass IIOur severity:Severe FDA (Devices)·Z-0147-2013·Announced 2012-10-31

DePuy Mitek Recalls SPIRALOK Bone Fixation Anchors Due to Fracture

DePuy Mitek is recalling 66 SPIRALOK bone fixation anchors because they can fracture after surgery, requiring patients to undergo revision surgery.

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 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 company, is recalling 66 units of SPIRALOK Anchors (Product Number 222967). These medical devices are primarily used to re-attach soft tissue to bone during rotator-cuff repair surgery, but are also indicated for use in the foot, ankle, knee, and elbow.

The recall was initiated because the anchors have fractured post-operatively, a defect that requires patients to undergo revision surgery. The recall covers all lot codes for this specific product number.

The affected devices were distributed worldwide, including nationwide in the United States and in numerous other countries such as Australia, Canada, Germany, and the United Kingdom. Patients who have had these anchors implanted should contact their healthcare provider to discuss the recall and potential need for revision surgery.

The recalled product

Product: Screw, fixation, boneProduct Number: 222967 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 Implant
Hazard: structural-failure
surgical-revision
Affected units: 66

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 →

Same manufacturer · DePuy Mitek, Inc., a Johnson & Johnson Co.

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