M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Reported: September 13, 2023 Initiated: July 26, 2023 #Z-2519-2023
Product Description
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Reason for Recall
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 24 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440). Recalled by Zimmer, Inc.. Units affected: 24 units.
Why was this product recalled? ▼
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 13, 2023. Severity: Moderate. Recall number: Z-2519-2023.
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