The Recall Desk
SevereFDA (Devices)·Z-0142-2013·Announced 2012-10-31

DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

DePuy Mitek is recalling 314 units of SpiraLok 6.5mm anchors because they may fracture after surgery, requiring patients to undergo 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 additional surgery (revision), meeting the criteria for a Severe rating.

Plain-English summary

DePuy Mitek, Inc., a Johnson & Johnson company, is recalling 314 units of SpiraLok 6.5mm anchors with Ethibond and needles (Product Number 222962). 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 was initiated because the anchors may fracture after the operation, which requires patients to undergo revision surgery. The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries.

Healthcare providers and patients who have used these specific anchors should contact DePuy Mitek or their healthcare provider for further instructions regarding the recall and potential revision procedures.

The recalled product

Product
SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 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
Affected units
314

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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