Teleflex Medical: Medical Device Recall in 2014 - (Recall #: Z-1296-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

Product Classification:

Class II

Date Initiated: March 11, 2014

Date Posted: April 2, 2014

Recall Number: Z-1296-2014

Event ID: 67733

Reason for Recall:

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Status: Terminated

Product Quantity: Total 32,271 ea.

Code Information:

Product Code: X-6371M5, Lot numbers: 02E0801603

Distribution Pattern:

Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

Voluntary or Mandated:

Voluntary: Firm initiated