Teleflex Medical Recalls Stainless Steel Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Deknatel stainless steel sutures because the needle may detach from the suture during use.
What this means for you
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 with a functional defect (needle detachment) that poses a risk of harm during surgical use, but the source text does not report any specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling 32,271 units of Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. The affected product is identified by Product Code X-4981M4 and Lot 02J0800451.
The recall was initiated because the product does not meet minimum needle attachment strength requirements. This defect means the needle can become detached from the suture during use. These sutures are used for fixation of bone fractures, bone reconstructions, as a guide pin for insertion of other implants, or implanted through the skin to apply traction to the skeletal system.
The affected units were distributed worldwide, including in the United States (specifically AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI) and in Canada, Germany, and Ireland. Healthcare providers and facilities should stop using the affected lots and contact Teleflex Medical for further instructions.
The recalled product
- Product
- Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the s
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Surgical Suture
- Affected units
- 32,271
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)
- Product Code X-4981M4 - Lot 02J0800451
Distribution
Part of a larger recall action
This product is one of 7 recalled by Teleflex Medical 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.
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