FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Synthes Trauma Nail System. The devices are indication for bone fixation.
- Recall number
- Z-2058-2013
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Synthes Trauma Nail System. The devices are indication for bone fixation.
- Status
- Terminated
- Initiated
- 2012-11-02
- Posted
- 2013-08-26
- Terminated
- 2016-09-27
- Reason
- Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
- Root cause
- Packaging change control
- Action
- The firm initiated their recall of this product on November 2, 2012 by sending an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter to all consignees. The letter explained the problem and gave instructions for consignees to examine their inventory and urged consignees to return the identified devices. The letter stated If returning the product would adversely impact their ability to provide necessary medical care to patients, they should re-sterilize the product per Pre-Vacuum Sterilization instructions contained in the Instruction for Use.
- Quantity
- 1,011,783
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897
- 510(k) numbers
- ["K011857","K033071","K033618","K040336","K040762"]
- PMA numbers
- not on file
- Product code
- HSB
- 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