FDA Medical Device Recalls (openFDA)
Linvatec Corp. dba ConMed Linvatec: REF 8788, 8mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in Arthroscopic knee procedures.
- Recall number
- Z-2248-2010
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Product
- REF 8788, 8mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in Arthroscopic knee procedures.
- Status
- Terminated
- Initiated
- 2010-01-28
- Posted
- 2010-08-24
- Terminated
- 2010-12-15
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Lot Number: 83491, 98286, 112009, and 116064.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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