DePuy I.M. Hole Locator Instrument Recalled for Fracture Risk
DePuy Orthopaedics is recalling 1,130 I.M. Hole Locator Instruments because excessive force during use may lead to intra-operative femoral fracture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (intra-operative femoral fracture), which aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,130 units of the I.M. Hole Locator Instrument. This is an orthopedic manual surgical instrument used to guide the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis.
The recall is issued because the use of excessive force when impacting the instrument may lead to intra-operative femoral fracture. The affected units are identified by Catalog No. 9505-01-041 and Barcode GTIN 10603295224389, covering all lots.
The products were distributed worldwide, including nationwide in the United States and in countries such as Canada, Australia, Austria, Belgium, the Czech Republic, France, Germany, India, Israel, Italy, Japan, Malaysia, Russia, South Africa, Switzerland, and the United Kingdom. Healthcare providers should stop using the affected instruments and contact DePuy Orthopaedics for further instructions.
The recalled product
- 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…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 1,130
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS
Distribution
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