FDA recall Z-1975-2021

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

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

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