SPINEART SA recalls PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle

Recalled July 7, 2021 · FDA recall Z-1975-2021 · SPINEART SA

Hazard

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

Units

44 units in the U.S.

Sold at

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

Description

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

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

Manufacturer(s)

SPINEART SA

Made in

Switzerland

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →