Z-1536-2018Class II

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

Name: Z-1536-2018 Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Creator: Smith & Nephew, Inc.
Published: 2017-12-11
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-12-11 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 on 2017-12-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1536-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-11
Posted: 2018-04-26
Terminated: 2020-09-21
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 12/11/2017, recall notifications were sent to Hospital Representatives, Affiliates/Distributors, and Sales Personnel. Notified consignees were instructed to inspect inventory and quarantine any affected devices, return the completed Inventory Return Certification Form, and return the affected product. In addition to the above, Affiliates and Distributors were instructed to forwarding the recall letter to customers and asking them to return any recalled product. Consignees were instructed to contact the firm via email at [email protected]
Quantity in commerce: 22
Distribution: Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Product codes and lots: Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1536-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1536-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26

Product code MAI

K952535Class IIAcufex Endobutton TapeAcufex Microsurgical, Inc. / cleared 1996-02-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)