Agency classClass IIOur severity:Severe FDA (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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: structural-failure
surgical-injury
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 →

Same manufacturer · Smith & Nephew, Inc. Endoscopy Division

See all →

High
Smith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach
FDA (Devices) · 2014-07-23
High
Smith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach
FDA (Devices) · 2014-07-23
High
Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
FDA (Devices) · 2014-07-23
Severe
Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
FDA (Devices) · 2014-07-23
High
Smith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach
FDA (Devices) · 2014-07-23

Same hazard · structural failure