FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
- Recall number
- Z-0604-2018
- Recalling firm
- Synthes (USA) Products LLC
- Product
- 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
- Status
- Terminated
- Initiated
- 2017-07-21
- Posted
- not on file
- Terminated
- 2018-07-10
- Reason
- The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
- Root cause
- Employee error
- Action
- The company issued a recall letter on 7/21/2017 asking customers to quarantine affected product and arrange for it to be returned.
- Quantity
- 4 units
- Distribution
- TX, GA, PA, UT and Canada
- Lot, serial or model codes
- Lot H302839, Expiration Date 31Jan2026
- 510(k) numbers
- ["K011857"]
- PMA numbers
- not on file
- Product code
- HSB
- 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