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
FDA Recall Z-1975-2021 · Posted None
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Recalling FirmSPINEART SA
Recall StatusTerminated
Product CodeNKB
Date Initiated2021-04-09
Date Terminated2022-09-29
Product Quantity44 units in the U.S.
Reason for Recall
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Firm 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: [email protected].
5. All returned products will be exchanged with batches already available in our warehouse.
Root Cause
Process control
Distribution Pattern
U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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