Recall Z-0546-2020

Reason for recall

Inner blister pack label is incorrect and does not match the correct external box label.

FDA-determined cause: Employee error

Action taken

On 02/05/2019, the firm sent an "URGENT: MEDICAL DEVICE RECALL FSCA-04-2019" notification letter via email informing its one U.S. Distributor of the issue of incorrect inner blister pack labeling for Lot Number 4-2899. The customer was instructed to please carefully follow instructions detailed below: 1. Immediately review their inventory and quarantine concerned products if any. 2. For customer who may have further distributed this product to please identify concerned customers and notify them at once of this product recall by using the URGENT: MEDICAL DEVICE RECALL" document. 3. Collect and quarantine all products. 4. Sent back all products with the enclosed Response Form to the Recalling Firm(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 the Recalling Firm's warehouse. The customers were also informed of the following risks associated with the affected product: The product is always selected before implantation by reading the external label. Consequently, the selection of a wrong size implant can be excluded. At worst the surgeon could be surprised to see that the internal label does not match with the external box label or the product itself regarding the size. A confusion would then be generated. In addition, the patient file information could be partially erroneous as the internal label is usually kept in the records. But the batch number that is good (4-2899) ensures a full traceability.