Z-2503-2010

GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only

Name: Z-2503-2010 GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2010-08-05
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2010-08-05 / Terminated / root cause: packaging

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only on 2010-08-05. The reason FDA records is "ConMed Linvatec, Largo, FL is recalling ConMed Linvatec 9263A,4.2mm Sterling Blade, Gator Meniscus Cutter, Lot Number 178026 for breech in the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2503-2010
Status: Terminated
Initiated: 2010-08-05
Posted: 2010-09-25
Terminated: 2010-12-14
Recalling firm: Linvatec Corporation
Product: GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
Reason for recall: ConMed Linvatec, Largo, FL is recalling ConMed Linvatec 9263A,4.2mm Sterling Blade, Gator Meniscus Cutter, Lot Number 178026 for breech in the sterile barrier.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Recall Notifications will be sent to all direct consignees by FedEx, email, Fax, etc. If the account no longer has the product in their possession, they will be asked to respond as such. A Return Material Authorizations Number will be assigned for the returned product as required. Product returned will be placed into quarantine and will be dispositioned in accordance with ConMed Linvatec procedures. 100% of the consignees will be contacted. The reply form is the mechanism to verify notification effectiveness to all consignees. If a reply is not received within approximately 30 business days of the first notification ConMed Linvatec will make two additional contacts by phone and / or email, as necessary, to insure all consignees have received notification and have taken appropriate action. If a reply is not received following the third contact by email or phone, no further contacts will be made to the consignee.
Quantity in commerce: 174
Distribution: Products were distributed to ConMed Linvatec consignees, sales representatives and affiliates within the US and Australia. US distribution was to WA, AZ, PA, KS, NM, UT, ID, IL. Products were distributed to ConMed Linvatec Australia.
Product codes and lots: Lot 178026

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)