FDA Device Recall Z-0034-2009: Surgical Specialties Corp

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0034-2009.

Recall Res Number

Z-0034-2009

Recalling Firm / Manufacturer

Surgical Specialties Corp

FEI Number

2522801

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-09-09

Date Posted

2008-10-02

Date Terminated

2009-03-27

Product Code

GAR

Event Number

49494

Product Quantity

956 boxes

Product Description 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.

Reason for Recall mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture

Action Details 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.

Distribution Pattern 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.

Code Information / Serial Numbers Lot number M335870

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Medical Device Recall: Z-0034-2009

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer