Z-2086-2015Class II

16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery...

Name: Z-2086-2015 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery...
Creator: Synthes (USA) Products LLC
Published: 2015-06-24
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-06-24 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument on 2015-06-24. FDA classified it as Class II and gives the reason as "It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade". 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-2086-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Posted: 2015-07-16
Terminated: 2016-08-18
Recalling firm: Synthes (USA) Products LLC
Product: 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
Product code: FZO Chisel, Surgical, Manual
Reason for recall: It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients were asked to check inventory and return affected devices along with the completed response form. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 100
Distribution: US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS.
Product codes and lots: Part Number 399.56 Lot Numbers T106341

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2086-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2086-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-16

Product code FZO

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)