# FDA recall Z-1975-2021

> **SPINEART SA** · Class II · device recall initiated 2021-04-09.

## 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.

## Distribution

U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided

## Key facts

- **Recall number:** Z-1975-2021
- **Recalling firm:** SPINEART SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-09
- **Report date:** 2021-07-07
- **Termination date:** 2022-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plan-Les-Ouates, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2021

## Citation

> AI Analytics. FDA recall Z-1975-2021. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-1975-2021. Source: US FDA. Licensed CC0.

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