The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2166-2012·Announced 2012-08-15

Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Breakage Risk

Smith & Nephew is recalling 4,661 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (anchor breakage during surgery) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling 4,661 units of the 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (white, COBRAID-blue), sterile, Part Number 72202895. 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. The affected units are distributed worldwide, including the United States and numerous international locations such as Canada, the United Kingdom, Germany, and Australia.

Healthcare providers and patients should stop using the affected lots and contact Smith & Nephew for instructions on how to return the product. The specific lot numbers affected are 50388181, 50389102, 50392406, 50394176, 50395679, 50395801, 50399411, 50400927, 50402475, 50403491, 50407007, 50410403, 50412883, 50414234, 50415663, 50416800, 50418329, 50419173, 50421006, and 50422555.

The recalled product

Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 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
4,661

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: 50388181
  • 50389102
  • 50392406
  • 50394176
  • 50395679
  • 50395801
  • 50399411
  • 50400927
  • 50402475
  • 50403491
  • 50407007
  • 50410403
  • 50412883
  • 50414234
  • 50415663
  • 50416800
  • 50418329
  • 50419173
  • 50421006
  • 50422555

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 →

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