PERLA TL Lateral Connector Open — Class II medical device recall Z-1975-2021
Terminated recall by SPINEART SA, reported 2021-07-07, distributed nationwide. Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
| Recall number | Z-1975-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SPINEART SA, Plan-Les-Ouates, N/A, Switzerland |
| Recall initiated | 2021-04-09 |
| Classified | 2021-06-28 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2022-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 44 units |
| Reason classes | labeling |
| Lot numbers | 15-S |
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 for recall
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1975-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.