Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
Reported: February 19, 2020 Initiated: December 16, 2019 #Z-1127-2020
Product Description
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
Reason for Recall
The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
Details
- Recalling Firm
- Nextremity Solutions
- Units Affected
- 40
- Distribution
- Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.. Recalled by Nextremity Solutions. Units affected: 40.
Why was this product recalled? ▼
The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1127-2020.
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