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U.S. Department of Health and Human Services

Class 2 Device Recall PERLA TL Lateral Connector Open

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  Class 2 Device Recall PERLA TL Lateral Connector Open see related information
Date Initiated by Firm April 09, 2021
Create Date June 28, 2021
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = Spineart
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