Z-0867-2017Class II

Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument

Name: Z-0867-2017 Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Creator: Synthes (USA) Products LLC
Published: 2016-11-29
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-11-29 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument on 2016-11-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0867-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-29
Posted: 2016-12-21
Terminated: 2017-08-03
Recalling firm: Synthes (USA) Products LLC
Product: Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Product code: FSM Tray, Surgical, Instrument
Reason for recall: 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 tag: manufacturing process
FDA 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: [email protected] 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 in commerce: 31 units
Distribution: Nationwide Distribution
Product codes and lots: Catalog ID (part # 60.119.012), Lot Number FL00528

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0867-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0867-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)