| Class 2 Device Recall YPlate | |
Date Initiated by Firm | April 06, 2018 |
Date Posted | June 07, 2018 |
Recall Status1 |
Terminated 3 on June 30, 2021 |
Recall Number | Z-2135-2018 |
Recall Event ID |
79819 |
510(K)Number | K140876 |
Product Classification |
Plate, fixation, bone - Product Code HRS
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Product | Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001) |
Code Information |
(UDI)/Lot: a) (18056099647786) B1102163; (b (18056099647793) B1106912 |
Recalling Firm/ Manufacturer |
Orthofix, Inc 3451 Plano Pkwy Lewisville TX 75056-9453
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For Additional Information Contact | Gianluca Ricadona 469-742-2500 |
Manufacturer Reason for Recall | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. |
FDA Determined Cause 2 | Device Design |
Action | On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier. |
Quantity in Commerce | 36 |
Distribution | U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK, |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HRS
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