Class 2 Device Recall Ally Bone ScrewL

• Date Initiated by Firm: March 29, 2019
• Create Date: June 25, 2020
• Recall Status: Terminated on May 27, 2022
• Recall Number: Z-2428-2020
• Recall Event ID: 85111
• 510(K)Number: K121713
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.
• Code Information: Model Number; PD 32 601 - ALLY Bone Screw L 10mm Lot Number: 046164 Model Number: PD 32 602 - ALLY Bone Screw L 12mm Lot Numbers: 045375 045646 045647 046313
• Recalling Firm/ Manufacturer: PROVIDENCE MEDICAL TECHNOLOGIES; 3875 Hopyard Rd Ste 300; Pleasanton CA 94588-8527
• For Additional Information Contact: Edward Liou; 415-923-9376 Ext. 3412
• Manufacturer Reason for Recall: There may be dimensional manufacturing error that represents a potential safety risk to patients.
• FDA Determined Cause: Component design/selection
• Action: On 03/29/2019, the firm sent an Customer Notification via email to Sales Representatives and Distributors who were in possession of the affected lots. The Customer Notification informed customers that the firm has determined that there may be non-conformances associated with bone screw and to not use any of the bone screws. Customer are instructed to: -immediately return the affected product, no later than 4/2/2019, and if they have any screws from different lots, these should also be returned. A return FedEx label is included with the email. Customers are also instructed that if the quantities of the product that they have on hand are different from the quantities provided in their email, they are to respond with a thorough explanation of the products whereabouts. Below is a list of potential reasons why the customer may not have the items in their possession. It is necessary to provide a complete accounting of the inventory the Recalling Firm's records show as in their possession. -Used in case and RPO is not yet submitted (provide RPO#) -Gave to (name of person) to support a case in their territory (date of transfer of inventory) -Currently stored at (name of customer) site (these need to be returned as well) -Presently stored at (name of location) (these need to be returned as well) -Returned to HQ on XX/XX/2019 -Converted for emergency demonstration purposes (date of conversion) For any questions, contact the Recalling Firm's Sales Manager or Chief Operating Officer at 415-923-9376
• Quantity in Commerce: 208 units
• Distribution: US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = HWC and Original Applicant = PROVIDENCE MEDICAL TECHNOLOGY, INC.