Z-2042-2016Class II

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

Name: Z-2042-2016 Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
Creator: SSC- Surgical Specialties Corporation
Published: 2016-05-20
License: https://open.fda.gov/license/

SSC- Surgical Specialties Corporation / initiated 2016-05-20 / Terminated / root cause: manufacturing process

FDA source

SSC- Surgical Specialties Corporation began a recall of Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N on 2016-05-20. FDA classified it as Class II and gives the reason as "Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 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-2042-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-20
Posted: 2016-06-21
Terminated: 2016-08-12
Recalling firm: SSC- Surgical Specialties Corporation
Product: Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
Product code: GAW Suture, Nonabsorbable, Synthetic, Polypropylene
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 36 boxes (432 units)
Distribution: TX, ME, MA, MI, OH, KS, MN, KS, TN, GA
Product codes and lots: MAPX540

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2042-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2042-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21

Product code GAW

K904906Class IISharpoint Polypropylene Nonabsorb Surg Sutures UspChathamborough Research Group, Inc. / cleared 1990-12-24

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)