FDA Device recall Z-1975-2021
PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft
- FDA Device
- Class II
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft by Spineart, citing due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1975-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-09 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Spineart |
| Distribution | US |
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
Reason
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Identifiers
| code_info | Reference Number/Product Description/Batch Number: -TLF-LC OP 15-S / PERLA TL Lateral Connector Open, 15mm / 5-2983…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1975-2021%22
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