Z-0987-2012

REF C9944A"FULL RADIUS RESECTOR"2.9mmQty 6STERLINGSTERILERx Only. Made in the...

Name: Z-0987-2012 ***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2009-11-12
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2009-11-12 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of ***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD... on 2009-11-12. The reason FDA records is "ConMed Linvatec, Largo, FL recalled catalog number, C9944A, lot # 95987, 2.9MM Full Radius Resector Blade in November 2009 because there was a possibility that the device was assembled with an incorrect outer tube". 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-0987-2012
Status: Terminated
Initiated: 2009-11-12
Posted: 2012-02-10
Terminated: 2012-02-13
Recalling firm: Linvatec Corporation
Product: ***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***ConMed Linvatec Biomaterials, Ltd.Hermiankatu 6-8L 33720 Tampere, FINLAND.***Lot number # 95987. Soft Tissue resection and removal.
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
Reason for recall: ConMed Linvatec, Largo, FL recalled catalog number, C9944A, lot # 95987, 2.9MM Full Radius Resector Blade in November 2009 because there was a possibility that the device was assembled with an incorrect outer tube.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: A Linvatec Corporation dba ConMed Linvatec sales representative contacted the affected customers by telephone on November 12, 2009. The customers were also contacted by the Recall Coordinator. The product, problem, and action to be taken by the customers were discussed. Customers with the product in their inventory were instructed to return the product to the firm. Contact the firm at 727-399-5205 for questions regarding this recall.
Quantity in commerce: 30 Units
Distribution: Product Distributed in the states of Georgia and New York.
Product codes and lots: Lot # 95987

Product code GFA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)