Z-2059-2012Class II

4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or...

Name: Z-2059-2012 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or...
Creator: Synthes USA HQ, Inc.
Published: 2012-05-22
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2012-05-22 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument... on 2012-05-22. FDA classified it as Class II and gives the reason as "Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2059-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-22
Posted: 2012-07-23
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated May 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this recall.
Quantity in commerce: 20
Distribution: Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.
Product codes and lots: Lot #2724103 Expiration 4/29/2012 REF 04.019.038S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2059-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2059-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-23
Z-2060-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-23

Product code HSB

K103002Class IISynthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) / cleared 2011-03-02

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