The Recall Desk
SevereFDA (Devices)·Z-0152-2013·Announced 2012-10-31

DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture

DePuy Mitek is recalling 25,393 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision.

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 has 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 25,393 units of SpiraLok 5.0 anchors with needles and violet and blue Orthocord (Product Number 222985). The recall is due to reports of the anchors fracturing after surgery, which has required patients to undergo revision surgery.

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 covers all lot codes and includes units 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 recall and potential risks. The FDA has classified this as a Class II recall, indicating that the use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 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
25,393

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.

See all →

Same hazard · fracture

See all →