Recall Z-1127-2020— Nextremity Solutions
Class II · Terminated
Class II FDA medical device recall by Nextremity Solutions, initiated 2019-12-16, terminated 2020-09-08. It names one FDA 510(k) clearance: K182201. Product: 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: 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..
- Recalling firm
- Nextremity Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-16
- Terminated
- 2020-09-08
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.