FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
- Recall number
- Z-2243-2013
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
- Status
- Terminated
- Initiated
- 2013-04-18
- Posted
- 2013-09-18
- Terminated
- 2015-03-30
- Reason
- Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
- Root cause
- Packaging process control
- Action
- A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested.
- Quantity
- 1
- Distribution
- US distribution to MA.
- Lot, serial or model codes
- Part Number 450.851S, Lot Number 7065061
- 510(k) numbers
- ["K970733"]
- PMA numbers
- not on file
- Product code
- HTY
- Firm FEI
- 3005180112
- 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