The Recall Desk
SevereFDA (Devices)·Z-2165-2012·Announced 2012-08-15

Smith & Nephew TWINFIX Ultra Ti Suture Anchor Recall for Breakage Risk

Smith & Nephew is recalling 913 units of TWINFIX Ultra Ti Suture Anchors because the distal part may break during insertion into bone.

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. The hazard involves a structural failure of a medical device during surgery, which poses a significant risk of injury to the patient, meeting the criteria for a Severe rating.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling 913 units of the 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles, Part Number 72202618. The product is intended for use for the reattachment of soft tissue to bone.

The recall was initiated because the distal part of the anchor may break on insertion into bone during surgery. The affected lot numbers are 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, and 50416842.

The products were distributed worldwide, including the United States, Canada, Puerto Rico, and various countries in Europe, Asia, South America, and Africa. Healthcare providers and facilities should stop using the affected devices and contact Smith & Nephew for instructions on return or replacement.

The recalled product

Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
Category
Medical Device — Orthopedic Suture Anchor
Hazard
Affected units
913

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 (7)

  • Lot Numbers: 50396501
  • 50396505
  • 50396506
  • 50397570
  • 50408062
  • 50412964
  • 50416842:

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Smith & Nephew, Inc. Endoscopy Division 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 4 products in this recall →

Related recalls

Same manufacturer · Smith & Nephew, Inc. Endoscopy Division

See all →

Same hazard · structural failure

See all →