Z-2087-2014Class II

Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic...

Name: Z-2087-2014 Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic...
Creator: Synthes, Inc.
Published: 2014-05-29
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-05-29 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument on 2014-05-29. FDA classified it as Class II and gives the reason as "The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The...". 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-2087-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Posted: 2014-07-21
Terminated: 2016-08-18
Recalling firm: Synthes GmbH
Product: Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An urgent field correction notification, dated May 29, 2014, was sent to end users and sales consultants which described the product, problem, and actions to be taken.
Quantity in commerce: 180
Distribution: Distribution US Nationwide and Bermuda.
Product codes and lots: part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2087-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2087-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-21

Product code LXH

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)