Lower riskMedical device recall · FDA · Published February 8, 2018
Tornier Phantom Fiber Sutures: Risk of Reduced Strength Due to Improper Storage
Tornier recalls Phantom Fiber sutures that may lose strength faster if improperly stored, potentially affecting surgical safety. Affected items include specific sizes and packaging. Consumers should check product details and contact Tornier for guidance.
Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.
Take action
Contact the company
📍Recalling firmTornier, Inc10801 Nesbitt Ave S · Bloomington, MN 55437-3109
“Tornier Phantom Fiber Sutures: Risk of Reduced Strength Due to Improper Storage.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/71994-tornier-phantom-fiber-sutures-risk-of-reduced-strength-due-to. Based on FDA recall #Z-1374-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1374-2018%22&limit=1).
The FDA announced on Feb. 8, 2018, that Tornier, Inc. voluntarily recalled Fornier Phantom Fiber(TM) Sutures due to potential degradation of raw materials if improperly stored. This issue may cause the suture to lose strength more quickly than expected. The recall affects approximately 32,253 units distributed nationwide.
Data indicates that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if the product is improperly stored. This degradation may impact the shelf-life of the product, which could cause the suture to lose strength more rapidly than anticipated.
Context
GovInfoNow's records show Tornier, Inc. has had 12 other recalls on record since March 26, 2018. Recent brand-specific actions include a March 5, 2026 recall of HRS Max Parts for incompatibility with the Tornier HRS Max system and a Dec. 19, 2025 recall of Perip Screws due to incorrect labeling that may cause surgery delays. Other recent recalls of similar products include a June 24, 2026 Covidien Dermalon 4-0 Blue 75cm Sutures Recall for risk of infection from packaging tears and a Dec. 17, 2025 Genesis Push-In Suture Anchor Recall for device failure risk.
How to tell if you have this one
Check for item numbers like SMB000425, SMB000525, SMP000425, or SMSB0110 in the product packaging. The sutures are sold in specific sizes and packaging for general soft tissue procedures.
Brand
Tornier
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for item numbers such as SMB000425, SMB000525, SMP000425, or SMSB0110 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1374-2018 (February 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1374-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.