Recall Z-1127-2020 · HRS Plate, Fixation, Bone
Nextremity Solutions
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.
| Date | Dec 16, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by 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 CorporateQuality.PostMarket@zimmerbiomet.com. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182201 | Stratum™ Foot Plating System Nextremity Solutions, Inc., Nov 16, 2018 |