FDA Medical Device Recalls (openFDA)
Linvatec Corp. dba ConMed Linvatec: CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
- Recall number
- Z-2147-2012
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Product
- CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
- Status
- Terminated
- Initiated
- 2011-08-12
- Posted
- 2012-08-06
- Terminated
- 2013-11-21
- Reason
- ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.
- Root cause
- Use error
- Action
- The firm sent an "URGENT: Medical Device Recall Notification" letter dated August 12, 2011, to its customers after initial phone notifications. The letter describes the product, problem and actions to be taken. The customers were instructed to: 1) Immediately check their facility's inventory for the product number and lot number listed in the letter. If the product is at their facility, they were instructed to discontinue the use of the product. 2) To return the products to ConMed Linvatec for credit and return the products and Reply Form. 3) If the product was transferred to another facility, complete the Reply Form documenting the transfer of the product, and return i by mail or fax. For questions, contact 727-399-5205.
- Quantity
- 2
- Distribution
- Nationwide Distribution, including the states of Colorado and Pennsylvania.
- Lot, serial or model codes
- Lot #156920
- 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