medical Class II Updated 2021-07-07

SPINEART SA recalls PERLA TL Lateral Connector Open - Product Usage: intended to

Recalled 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

Hazard / Issue

Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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