RecallRadar

FDA Device recall Z-1535-2014

Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile

On 2014-05-07 the FDA classified a Class II recall of Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile by Teleflex Medical, citing the product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1535-2014
ClassificationClass II
Statusterminated
Initiated2014-03-11
Published2014-05-07
Last updated2026-09-13 11:53 UTC
CompanyTeleflex Medical
DistributionUS

Product

Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.

Reason

The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

Identifiers

code_infoProduct Code: 200101-01, Lot # 02F0801290 and Product Code: BP1000V2L, Lot numbers: 02C1003535 & 02F1000711.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1535-2014%22

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