The Recall Desk
SevereFDA (Devices)·Z-0148-2013·Announced 2012-10-31

DePuy Mitek Recalls Seven SpiraLok 5.0 Anchors Due to Fracture

DePuy Mitek is recalling seven SpiraLok 5.0 anchors because they fractured after surgery, requiring patients to undergo revision procedures.

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 seven units of SpiraLok 5.0 anchors with needles and Orthocord (Product Number 222968). 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 fractured after surgery, which required patients to undergo revision procedures. The affected units were distributed worldwide, including in the United States and numerous other countries.

Patients who have had these specific anchors implanted should contact their healthcare provider to discuss the recall and potential next steps.

The recalled product

Product
SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 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
7

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 · structural failure

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