FDA Medical Device Recalls (openFDA)
Linvatec Corp. dba ConMed Linvatec: CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.
- Recall number
- Z-2585-2010
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Product
- CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.
- Status
- Terminated
- Initiated
- 2010-01-29
- Posted
- 2010-09-28
- Terminated
- 2011-01-12
- Reason
- There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage.
- Root cause
- Process control
- Action
- Recall Notification Letters were sent to customers on January 29, 2010. Customers were requested to complete and return a Customer Response Form indicating the number of products available for return and number distributed. Each distributor was asked to notifiy their customers if the product was further distributed.
- Quantity
- 149
- Distribution
- Distributed throughout U.S. and Internationally to Arab Emirates, Belgium, Canada, China, Columbia, Cyprus, Germany, Denmark, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Republic of Korea, Lithuania, Morocco, Malaysia, Poland, Portugal, Saudi Arabia, El Salvador, Thailand, Taiwan and Viet Nam. Domestic Distribution to CA, FL, GA, IL, IN, KS, MI, MT, NY, OH, PA, TX, and WA.
- Lot, serial or model codes
- Lot Numbers 11708A, 11708B, 11708C, 11708D, 11708E
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZW
- 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