Recall Z-1536-2018— Smith & Nephew, Inc.

Name: FDA recall Z-1536-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-11

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-12-11, terminated 2020-09-21. It names one FDA 510(k) clearance: K952535. Product: Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015. Reason: Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-11
Terminated: 2020-09-21
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K952535 — ACUFEX ENDOBUTTON TAPEAcufex Microsurgical, Inc.·cleared 1996-02-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015

Reason for recall

Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.