Z-2245-2010

REF 8570 MENISCAL REPAIR NEEDLE, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908...

Name: Z-2245-2010 REF 8570 MENISCAL REPAIR NEEDLE, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2010-01-28
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2010-01-28 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of REF 8570 MENISCAL REPAIR NEEDLE, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in meniscal repairs on 2010-01-28. The reason FDA records is "This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents". 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-2245-2010
Status: Terminated
Initiated: 2010-01-28
Posted: 2010-08-24
Terminated: 2010-12-15
Recalling firm: Linvatec Corporation
Product: REF 8570 MENISCAL REPAIR NEEDLE, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in meniscal repairs.
Product code: HWQ Passer
Reason for recall: This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.
Quantity in commerce: 35,451 total
Distribution: Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S.
Product codes and lots: Lot Number: 46689, 12055, 73890, 82337, 83411, 83409, 82336, 83408, 82335, 96154, 97820, 96153, 96152, 102390, 106101, 106976, 107301, 117737, and 117736.

Product code HWQ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)