FDA Medical Device Recalls (openFDA)
Synthes, Inc.: Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
- Recall number
- Z-0986-2014
- Recalling firm
- Synthes, Inc.
- Product
- Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
- Status
- Terminated
- Initiated
- 2014-01-27
- Posted
- 2014-02-16
- Terminated
- 2015-12-18
- Reason
- Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
- Root cause
- Labeling Change Control
- Action
- A recall notification letter, dated January 27, 2013, was sent to End Users and sales consultants.
- Quantity
- 1,132,096
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
- Lot, serial or model codes
- part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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