CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
I.M. Hole Locator Instrument. Orthopedic manual surgical recalled
DePuy Orthopaedics is recalling I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator, distributed nationwide in the US. The recall was initiated on 12 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0908-2015
- FDA event ID
- 70046
- Recalling firm
- DePuy Orthopaedics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2014
- FDA classified
- 5 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Lead & Heavy Metals
- Device type
- Hip & Knee Implants
Timeline
| 12 Nov 2014 | Recall initiated by company | |
| 5 Jan 2015 | Classified by FDA | +54 days |
| 14 Jan 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Use of excessive force when impacting may lead to intra-operative femoral fracture.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMontanaNorth CarolinaNevadaNew York
Questions about this recall
Is I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator recalled?
Yes. DePuy Orthopaedics recalled I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator on 12 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0908-2015.
Why was it recalled?
Use of excessive force when impacting may lead to intra-operative femoral fracture.
Which lots are affected?
CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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