Z-0408-2014Class II

Slipped Capital Femoral Epiphysis System

Name: Z-0408-2014 Slipped Capital Femoral Epiphysis System
Creator: Synthes USA HQ, Inc.
Published: 2013-07-31
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-07-31 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral... on 2013-07-31. FDA classified it as Class II and gives the reason as "There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery". 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-0408-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-11-27
Terminated: 2015-06-01
Recalling firm: Synthes GmbH
Product: Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
Product code: HTW Bit, Drill
Reason for recall: There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
Root cause tag: design
FDA root cause: Device Design
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.
Quantity in commerce: 166
Distribution: USA Nationwide Distribution
Product codes and lots: Parts 03.207.001 and 03.207.008 with lot numbers: Part # Lot # 03.207.001 PE00376 PE00439 PE01391 PE01329 PE01412 PE00504 03.207.008 PE00440 PE00377 PE00513 PE01475 PE01691

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0408-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0408-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

Product code HTW

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)