Tornier Recalls Phantom Fiber Sutures Due to Potential Strength Loss
Tornier, Inc. is recalling 32,253 units of Phantom Fiber sutures because improper storage may cause the raw material to degrade, leading to a loss of suture strength.
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 medical device where the product may lose strength, posing a risk of harm during surgical procedures, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Tornier, Inc. is recalling 32,253 units of Fornier Phantom Fiber sutures, including various biocomposite and PEEK suture anchors and suture sizes. The recall covers all lots of the affected products, which were distributed nationwide in the United States.
The recall was initiated because data indicates that a raw material used in the Phantom Fiber may degrade more quickly than expected if the product is improperly stored. This degradation may impact the shelf-life of the product, potentially causing the suture to lose strength more quickly than anticipated.
The Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but is not intended for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery. Consumers and healthcare providers should stop using the affected products and contact Tornier, Inc. for further instructions.
The recalled product
- Product
- Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM…
- Manufacturer
- Tornier, Inc
- Affected units
- 32,253
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
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