ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Reported: November 19, 2014 Initiated: October 15, 2014 #Z-0199-2015
Product Description
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Reason for Recall
Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 3,082
- Distribution
- Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, UAE, United Kingdom and Chile.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag. Recalled by DePuy Orthopaedics, Inc.. Units affected: 3,082.
Why was this product recalled? ▼
Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2014. Severity: Moderate. Recall number: Z-0199-2015.
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