ULTRA-FAST FIX Knot Pusher Suture Cutters recallZ-1822-2015 · Smith & Nephew, Inc. · initiated Apr 30, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility of device maybe compromised
FDA root cause category: Package design/selection
What the company is doing
Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at [email protected] or fax +1-901-566-7975 to obtain a return authorization (RA) number
Recall details
- Recall number
- Z-1822-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 30, 2015
- Posted by the FDA
- Jun 22, 2015
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 202,279 units
- Product code
- GAT
- FDA submissions
- K132079
- Distribution
- Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.
Product description
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Code information (models, lots, serial numbers)
All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019
Other devices under the same FDA submission
1 device cleared under K132079 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FAST-FIX 72203986Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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