The Recall Desk
SevereFDA (Devices)·Z-2168-2012·Announced 2012-08-15

Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Breakage Risk

Smith & Nephew is recalling 4,411 units of TWINFIX Ultra Ti 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. Per the rubric, FDA Class II recalls with potential for significant injury or structural defects in medical devices are rated as Severe (4), as the breakage of an anchor during surgery poses a risk of adverse health consequences.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling 4,411 units of the 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile, Part Number 72202897. The product is intended for use for the reattachment of soft tissue to bone.

The recall is being conducted because the distal part of the anchor may break on insertion into bone during surgery. This is an FDA Class II recall, which means there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected units were distributed worldwide, including the United States and numerous international locations such as Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Denmark, Dubai, Finland, France, Germany, Greece, India, Italy, Korea, Malaysia, Mexico, Netherlands, Norway, Portugal, Puerto Rico, Shanghai, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. Specific lot numbers are listed in the source metadata. Healthcare providers and patients should contact Smith & Nephew for further instructions on how to proceed with the recall.

The recalled product

Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
Category
Medical Device — Orthopedic Anchor
Hazard
Affected units
4,411

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 (20)

  • Lot Numbers: 50388188
  • 50389268
  • 50392431
  • 50393764
  • 50394899
  • 50395675
  • 50396849
  • 50397464
  • 50398727
  • 50399817
  • 50400184
  • 50402082
  • 50403278
  • 50405085
  • 50406197
  • 50406805
  • 50408994
  • 50410001
  • 50412043
  • 50412967

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

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Same hazard · device breakage

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