PERLA TL Lateral Connector Open Spinal Fusion Devices Recalled for External Label Error
SPINEART SA is recalling 44 units of PERLA TL Lateral Connector Open spinal fusion connectors distributed in the U.S. due to external labels that incorrectly list the rod size.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II recall of a spinal fusion connector with incorrect rod size listed on external labels. Although no injuries have been reported, incorrect labeling on a surgical implant device presents a risk of harm if not verified before use.
Plain-English summary
SPINEART SA is recalling 44 units of PERLA TL Lateral Connector Open spinal fusion connectors (15mm and 30mm models) distributed in California, Massachusetts, and North Carolina. The devices were distributed with external labels that incorrectly list the rod size.
These lateral connectors are intended for use with autograft and/or allograft in spinal fusion procedures, with pediatric pedicle screw fixation limited to posterior approach. The labeling error could lead to incorrect product selection if the wrong rod size is chosen based on the mislabeled external packaging.
Healthcare facilities and providers that received these products should verify the actual product contents against what is labeled on the external packaging. Anyone with concerns about devices they may have received should contact the manufacturer, SPINEART SA, or their medical device supplier.
The recalled product
- 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
- SPINEART SA
- Category
- Medical Device — Spinal Fusion
- Hazard
- Affected units
- 44
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 15mm / 5-2983 -TLF-LC OP 30-S / PERLA TL Lateral Connector Open
- 30mm / 5-2993
Distribution
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