FDA Medical Device Recalls (openFDA)
Linvatec Corp. dba ConMed Linvatec: ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
- Recall number
- Z-1680-2013
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Product
- ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
- Status
- Terminated
- Initiated
- 2013-05-30
- Posted
- 2013-07-10
- Terminated
- 2013-09-04
- Reason
- Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.
- Root cause
- Equipment maintenance
- Action
- ConMed Linvatec sent an "URGENT: Medical Device Recall Notification" letter by FedEx next day delivery or equivalent on 5/30/2013 to all domestic direct consignees. ConMed Linvatec is translating customer notifications letters into the necessary languages and will send International notification letters no later than 6/4/2013.
- Quantity
- 4,691 Units total of each
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan.
- Lot, serial or model codes
- C7120 Lot's #: 1301184, 1301214, 1301254, 1301284, 1301294, 1302014, 1302044, 1302054, 1302064, 1302074, 13020124, 1302134, 1302144, 1302194, 1302204, 1302214, 1302224, 1302254, 1302264, 1303014, 1303054, 1303064, 1303074, 1303114, 1303124, 1303204, 1303214, 1303264, 1303274, 1303284, 1304014, 1304034, 1304054, 1304154, 1304294, 1304304, and 1305014.
- 510(k) numbers
- ["K954440"]
- 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