CLASS II Device recall · Reported 14 May 2014 · FDA Enforcement Report

Deknatel Teleflex Medical Silk Black Braided Silk Suture recalled

Teleflex Medical is recalling Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture, distributed in 28 states. The recall was initiated on 11 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code X-6371M5 - Lot 02E0801603

Quantity recalled32,271 ea.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1561-2014
FDA event ID: 67711
Recalling firm: Teleflex Medical, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2014
FDA classified: 6 May 2014
Reported: 14 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

11 Mar 2014	Recall initiated by company
6 May 2014	Classified by FDA	+56 days
14 May 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.

Where it was distributed

Worldwide Distribution -- USA, including the states of 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 countries of Canada, Germany, and Ireland.

Alabama California Florida Georgia Illinois Indiana Kansas Louisiana Massachusetts Maine Michigan Minnesota Missouri Mississippi New Jersey New Mexico Nevada New York Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Which lots are affected?

Product Code X-6371M5 - Lot 02E0801603

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 67711

This product is part of a recall event; the main page for the event is Deknatel Teleflex Medical Stainless Steel recalled.

Reported	Class	Recall	Company	Reason	Where
14 May 2014	CLASS II	Deknatel Teleflex Medical Stainless Steel recalled	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Research Triangle Park, NC, Polypropylene recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Research Triangle Park, NC, Braided Polyester recalled	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Nonabsorbable Surgical Suture, U.S.P., Sterile recalled	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid recalled	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Bard Fixt Suture Braided Polyester recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	28 states

More recalls from Teleflex Medical

All 235

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23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled	Teleflex Medical	Other	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
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2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide