FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
- Recall number
- Z-0406-2014
- Recalling firm
- Synthes (USA) Products LLC
- Product
- Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
- Status
- Terminated
- Initiated
- 2013-07-30
- Posted
- 2013-11-27
- Terminated
- 2015-08-17
- Reason
- A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.
- Root cause
- Labeling mix-ups
- Action
- Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.
- Quantity
- 13
- Distribution
- Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada.
- Lot, serial or model codes
- Part No. 249.926, lot No. 8093100
- 510(k) numbers
- ["K001941"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- 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