Class 2 Device Recall PERLA TL Lateral Connector Open

• Date Initiated by Firm: April 09, 2021
• Create Date: June 28, 2021
• Recall Status: Terminated on September 29, 2022
• Recall Number: Z-1975-2021
• Recall Event ID: 87971
• 510(K)Number: K193396
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm
• Code Information: Reference Number/Product Description/Batch Number: -TLF-LC OP 15-S / PERLA TL Lateral Connector Open, 15mm / 5-2983 -TLF-LC OP 30-S / PERLA TL Lateral Connector Open, 30mm / 5-2993
• FEI Number: 3007728266
• Recalling Firm/ Manufacturer: SPINEART SA; Chemin Du Pre-Fleuri 3; Plan-Les-Ouates Switzerland
• Manufacturer Reason for Recall: Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
• FDA Determined Cause: Process control
• Action: On 04/12/2021, the firm sent an email to its US Distribution Center and a follow-up "URGENT: MEDICAL DEVICE RECALL" letter (dated April 14, 2021) TO inform customers that the recall was being initiated due to an external labelling error where the external labels were mixed-up for two batches and could lead to confusion for the hospital staff and induce a minimal surgery delay. Customers are instructed to: 1. Immediately review their inventory and quarantine concerned products if any. 2. If they may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document. 3. Collect and quarantine all products. 4. Sent back all products with the enclosed Response Form to Spineart Geneva (Chemin du Pr Fleuri 3, 1228 Plan-les-Ouates, Switzerland). E-mail: regulatory@spineart.com. 5. All returned products will be exchanged with batches already available in our warehouse.
• Quantity in Commerce: 44 units in the U.S.
• Distribution: U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided
• 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 = NKB