Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Potential Breakage
Smith & Nephew is recalling 2,204 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 involves a risk-of-harm product (medical device) where the hazard is a potential mechanical failure during surgery, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling 2,204 units of the 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile, Part Number 72202896. The product is intended for the reattachment of soft tissue to bone.
The recall is being issued because the distal part of the anchor may break on insertion into bone during surgery. The affected lots are: 50388182, 50389253, 50391626, 50392272, 50392407, 50395081, 50395680, 50396197, 50400556, 50401558, 50402228, 50403940, 50406036, 50407582, 50409406, 50413407, 50414970, 50412647, 50415864, 50416801, 50418088, 50420654, 50421030, and 50421495.
The products were distributed worldwide, including the United States, Canada, Puerto Rico, and numerous countries in Europe, Asia, South America, and the Middle East. Healthcare providers should stop using the affected devices and contact Smith & Nephew for further instructions.
The recalled product
- Product
- Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Category
- Medical Device — Surgical Anchor
- Hazard
- Affected units
- 2,204
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: 50388182
- 50389253
- 50391626
- 50392272
- 50392407
- 50395081
- 50395680
- 50396197
- 50400556
- 50401558
- 50402228
- 50403940
- 50406036
- 50407582
- 50409406
- 50413407
- 50414970
- 50412647
- 50415864
- 50416801
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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Similar recalls
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