Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
Reported: April 25, 2018 Initiated: March 29, 2018 #Z-1381-2018
Product Description
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
Reason for Recall
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf
- Distribution
- Worldwide Distribution - USA (nationwide) to the states of : AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Australia, South Korea, Malaysia, Netherlands, and Singapore.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.. Recalled by Zimmer Biomet, Inc.. Units affected: 1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf.
Why was this product recalled? ▼
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1381-2018.
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