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.
FDA Recall Z-1127-2020 · Posted None
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Recalling FirmNextremity Solutions
Recall StatusTerminated
Product CodeHRS
Date Initiated2019-12-16
Date Terminated2020-09-08
Product Quantity40
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.
Firm Action
On December 16, 2019, the firm notified customers and distributors via recall notification letter and e-mail. The notification instructed return of all product with the specified lot number.
If customers have any questions, please call customer service at 574-371-3071 between 8AM-5PM EST, Monday thru Friday. Alternatively, questions may be emailed to [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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