Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
Reported: March 4, 2015 Initiated: December 17, 2014 #Z-1133-2015
Product Description
Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
Reason for Recall
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Details
- Recalling Firm
- Zimmer Gmbh
- Units Affected
- 30
- Distribution
- Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
- Location
- Winterthur, N/A
Frequently Asked Questions
What product was recalled? ▼
Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.. Recalled by Zimmer Gmbh. Units affected: 30.
Why was this product recalled? ▼
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2015. Severity: Moderate. Recall number: Z-1133-2015.
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