SPINEART SA: Medical Device Recall in 2021 - (Recall #: Z-1975-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 9, 2021

Date Posted: July 7, 2021

Recall Number: Z-1975-2021

Event ID: 87971

Reason for Recall:

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

Status: Terminated

Product Quantity: 44 units in the U.S.

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated