Z-1062-2013Class II

Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional...

Name: Z-1062-2013 Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional...
Creator: Synthes USA HQ, Inc.
Published: 2013-01-11
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-01-11 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures on 2013-01-11. FDA classified it as Class II and gives the reason as "Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1062-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-04-05
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.
Root cause tag: design
FDA root cause: Device Design
Action: Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter requested consignees examine inventory, remove the recalled products from use and return them to Synthes. If you have any questions, contact the firm at 610-719-5450.
Quantity in commerce: 328
Distribution: Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.
Product codes and lots: Part number 355.28, all lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1062-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1062-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-05

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