NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Reported: May 24, 2017 Initiated: April 28, 2017 #Z-2115-2017
Product Description
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Reason for Recall
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 24
- Distribution
- Worldwide Distribution - US Distribution to the states of: WI, CA, PA, NJ, IN, VA, WA, MN and HI ., and to the countries of : Brazil, Canada, Australia, Netherlands, Germany, Iran and Nigeria. VA/DOD: None
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.. Recalled by Zimmer Biomet, Inc.. Units affected: 24.
Why was this product recalled? ▼
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Moderate. Recall number: Z-2115-2017.
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