Recall Z-1975-2021 · NKB Thoracolumbosacral Pedicle Screw System
SPINEART SA
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
| Date | Apr 9, 2021 |
| Status | Terminated |
| Reason | Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size. |
| Root 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 o |
| Quantity | 44 units in the U.S. |
| Distribution | U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193396 | PERLA® TL posterior osteosynthesis system Spineart, Feb 5, 2020 |