Device 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
Z-1975-2021
Product summary
- Firm
- SPINEART SA
- Event
- Event 87971
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44 units in the U.S.
- Official record key
device-enforcement:Z-1975-2021
Official wording
Reason: Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
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
Derived failure modes
-
Unknown
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.