FDA-Device2021-07-07Class II
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
SPINEART SA
Hazard
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Sold states
U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided
Affected count
44 units in the U.S.
Manufactured in
Chemin Du Pre-Fleuri 3, N/A, Plan-Les-Ouates, N/A, Switzerland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2021Don't want to check this manually?
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