Agency classClass IIOur severity:Severe FDA (Devices)·Z-0143-2013·Announced 2012-10-31

SpiraLok 6.5mm Anchors Recalled Due to Post-Operative Fracture

DePuy Mitek is recalling 372 units of SpiraLok 6.5mm anchors because they fractured after surgery, requiring patient revision.

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 resulted in significant injury requiring revision surgery, meeting the criteria for a Severe rating.

Plain-English summary

DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 372 units of SpiraLok 6.5mm anchors with Panacryl and needles (Product Number 222963). 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 patient revision surgery. The agency has classified this as a Class II recall. The affected units were distributed worldwide, including the United States and numerous international markets.

Healthcare providers and patients who have received these specific anchors should contact DePuy Mitek for further instructions regarding the recall and potential revision procedures.

The recalled product

Product: SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 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: structural-failure
surgical-revision
Affected units: 372

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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