Z-2192-2010

REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY...

Name: Z-2192-2010 REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2010-07-06
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2010-07-06 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small... on 2010-07-06. The reason FDA records is "ConMed Linvatec Largo, FL is recalling 87K Arthroscopy Tubing Set, Product Number 87100, Lots 0904151 to and including 1005201. Product may have a breach in the seal that could potentially compromise the sterility of...". 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-2192-2010
Status: Terminated
Initiated: 2010-07-06
Posted: 2010-08-09
Terminated: 2011-02-24
Recalling firm: Linvatec Corporation
Product: REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small Joint Cannula System. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Made in USA. The 87K Arthroscopy Tubing Set is designed for use with the 87K Arthroscopy Pump System. This system can be used in arthroscopic procedures using fluid irrigation for joint distension. This system may be used where gravity systems are currently in use such as knee, shoulder, ankle and elbow arthroscopy.
Product code: HRX Arthroscope
Reason for recall: ConMed Linvatec Largo, FL is recalling 87K Arthroscopy Tubing Set, Product Number 87100, Lots 0904151 to and including 1005201. Product may have a breach in the seal that could potentially compromise the sterility of the contents.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ConMed Linvatec Corporation sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 6, 2010, via FedEx next day delivery to all customers. The letter described the product, problem and action to be taken by customers within 30 days of receipt of the letter. The customers were asked to PLEASE DISCONTINUE USE OF THE IDENTIFIED PRODUCT WITH LOT NUMBERS BEGINNING WITH 0904151 THROUGH AND INCLUDING 1005201; to immediately check their inventory for the affected lots number and Do Not Use if they have any of the products; to complete and return a Reply Form and to notify their customers if the product was further distributed and return all unused affected product with lot codes starting 0904151 to and including 1005201, to ConMed Corporation, 525 French Road, Utica, NY 13502. On receipt, ConMed Linvatec will issue credit to customers. Should you have any additional questions, please contact our Customer Service department at 800-535-8536 or fax at 727-319-5701 or email: [email protected]
Quantity in commerce: 97,830
Distribution: Worldwide distribution: USA and Canada.
Product codes and lots: Lot 0904151 through 1005201.

Product code HRX

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)