Z-1557-2013Class II

Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011

Name: Z-1557-2013 Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
Creator: Synthes USA HQ, Inc.
Published: 2013-02-22
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-02-22 / Terminated

FDA source

Synthes USA HQ, Inc. began a recall of Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011 on 2013-02-22. FDA classified it as Class II and gives the reason as "The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1557-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-22
Posted: 2013-06-19
Terminated: 2015-05-21
Recalling firm: Synthes GmbH
Product: Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
Product code: HRS Plate, Fixation, Bone
Reason for recall: The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.
FDA root cause: Under Investigation by firm
Action: The firm initiated their recall of the product on February 22, 2013 by sending an "Urgent Notice: Medical Device Recall" letter to the firm's sales representatives. The letter requested they examine their inventory, and/or customers inventories for the Part Number and if found, return it to Synthes for appropriate disposition.
Quantity in commerce: 10
Distribution: Nationwide distribution.
Product codes and lots: Part Number 241.000.011, lot number S2004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1557-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1557-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-19

Product code HRS

K011335Class IISynths One-Third Tubular Dcl PlateSynthes (Usa) / cleared 2001-07-27

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)