FDA Medical Device Recalls (openFDA)
Linvatec Corp. dba ConMed Linvatec: 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.
- Recall number
- Z-2192-2010
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- 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.
- Status
- Terminated
- Initiated
- 2010-07-06
- Posted
- 2010-08-09
- Terminated
- 2011-02-24
- Reason
- 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
- 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: Custerserv1@linvatec.com
- Quantity
- 97,830
- Distribution
- Worldwide distribution: USA and Canada.
- Lot, serial or model codes
- Lot 0904151 through 1005201.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 1017294
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28