Recall Z-1975-2021— SPINEART SA
Class II · Terminated
Class II FDA medical device recall by SPINEART SA, initiated 2021-04-09, terminated 2022-09-29. It names one FDA 510(k) clearance: K193396. 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..
- Recalling firm
- SPINEART SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-09
- Terminated
- 2022-09-29
- Firm location
- Plan-Les-Ouates, N/A, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.