ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Reported: September 1, 2021 Initiated: July 1, 2021 #Z-2348-2021
Product Description
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Reason for Recall
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 7 units
- Distribution
- International distribution in the countries of Canada, France.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080. Recalled by DePuy Orthopaedics, Inc.. Units affected: 7 units.
Why was this product recalled? ▼
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Moderate. Recall number: Z-2348-2021.
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