Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1295-2014.
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1295-2014.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Teleflex Medical or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1295-2014.
Teleflex Medical
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Teleflex Medical Recall FAQ
Teleflex Medical is the subject of a medical implants safety report: Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone .... The notice was published on March 11, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 32,271 units are potentially affected.