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Terminated

Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N

FDA Recall Z-2042-2016 · Posted None

Recalling FirmSSC- Surgical Specialties Corporation
Recall StatusTerminated
Product CodeGAW
Date Initiated2016-05-20
Date Terminated2016-08-12
Product Quantity36 boxes (432 units)

Reason for Recall

Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.

Firm Action

A customer notification letter dated 5/20/16 was sent to all customers to inform them that Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture. Customers are instructed to complete the attached customer acknowledgement form and return via fax to Surgical Specialties' Quality Assurance department at (610) 404-4010 or return via email to [email protected]. Customers with any questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.

Root Cause

Process control

Distribution Pattern

TX, ME, MA, MI, OH, KS, MN, KS, TN, GA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K904906SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USPChathamborough Research Group, Inc. · 1990-12-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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