FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
- Recall number
- Z-0429-2014
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
- Status
- Terminated
- Initiated
- 2013-08-01
- Posted
- 2013-11-29
- Terminated
- 2015-04-16
- Reason
- The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
- Root cause
- Use error
- Action
- Synthes sent an Field Safety Notification letter dated August 1, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following actions: Exchange the old surgical technique guide with the new guide version F provided with this notification. Review the revised surgical technique guide. Forward this Field Safety Notification to anyone in your facility that needs to be informed. If the technique guide has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all technique guides have been exchanged. Maintain a copy of this notice. Please complete and return this page by either of the following methods: Fax: 877-567-9320 or Scan/email: FieldAction@synthes.com Thank you for your attention to this issue.
- Quantity
- 374
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.
- Lot, serial or model codes
- Part J5957AC (old), and Part J5957F (new)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAD
- 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