Z-0034-2009

3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general...

Name: Z-0034-2009 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general...
Creator: Surgical Specialties Corp
Published: 2008-09-09
License: https://open.fda.gov/license/

Surgical Specialties Corp / initiated 2008-09-09 / Terminated / root cause: manufacturing process

FDA source

Surgical Specialties Corp began a recall of 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including... on 2008-09-09. The reason FDA records is "mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture". 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-0034-2009
Status: Terminated
Initiated: 2008-09-09
Posted: 2008-10-02
Terminated: 2009-03-27
Recalling firm: Surgical Specialties Corp
Product: 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Product code: GAR Suture, Nonabsorbable, Synthetic, Polyamide
Reason for recall: mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm issued a Recall letter dated 9/9/08 to its customers. The letter informed the customers of the problem, the need to conduct a sub-recall, and return the product. Contact Surgical Specialties Corp. at 1-610-404-1000 for assistance.
Quantity in commerce: 956 boxes
Distribution: USA--AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MD, MI, MS, NC, NJ, NY, OH, TN, TX, VA, and WA. OUS: Australia, Canada, and Fiji Islands.
Product codes and lots: Lot number M335870

Product code GAR

K930825Class IISuture Nonabsorbable-Nylon,silk,polyester,stainlesSurgical Specialties, Inc. / cleared 1994-01-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)