FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
- Recall number
- Z-0867-2017
- Recalling firm
- Synthes (USA) Products LLC
- Product
- Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
- Status
- Terminated
- Initiated
- 2016-11-29
- Posted
- 2016-12-21
- Terminated
- 2017-08-03
- Reason
- The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.
- Root cause
- Process control
- Action
- DePuy Synthes mailed an Urgent Notice Medical Device Recall letter to all affected customers informing them of the potential impacts, actions to be taken and instructions for the product return. Customers were instructed to immediately review their inventory to identify and quarantine all affected products, complete the attached Verification Section and send a copy to Depuy Synthes by scan/email: Synthes5748@stericycle.com or fax to 1-888-943-5169. If any of the affected product has been forwarded to another facility, contact the facility to arrange return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant.
- Quantity
- 31 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Catalog ID (part # 60.119.012), Lot Number FL00528
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSM
- 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