Z-0908-2015Class II

I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill...

Name: Z-0908-2015 I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill...
Creator: DePuy Orthopaedics, Inc.
Published: 2014-11-12
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2014-11-12 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is... on 2014-11-12. FDA classified it as Class II and gives the reason as "Use of excessive force when impacting may lead to intra-operative femoral fracture". 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-0908-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-12
Posted: 2015-01-05
Terminated: 2015-02-24
Recalling firm: Depuy Orthopaedics Inc.
Product: I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Use of excessive force when impacting may lead to intra-operative femoral fracture.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, DePuy Synthes, sent an "URGENT INFORMATION - DEVICE CORRECTION NOTICE HP LCS IM Hole Locator" notification dated November 12, 2014 to the affected distributors. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The distributors were instructed to: review the instructions and the information in this notice; provide this notice to your sales consultants, and complete and return the DISTRIBUTOR RESPONSE CARD: Verify Sales Consultant Notifications via fax to (574) 371-4939 or email: [email protected]. For questions, please contact Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EST).
Quantity in commerce: 1130
Distribution: Worldwide Distribution: US (nationwide) including states of: AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, NC, NV, NY, OH, PA, TN, TX, VA, WA, and WI; and countries of: Canada, Australia, Austria, Belgium, Czech Republic, France, Germany, India, Israel, Italy, Japan, Malaysia, Russia, South Africa, Switzerland, and United Kingdom.
Product codes and lots: CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0908-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0908-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)