The Recall Desk
HighFDA (Devices)·Z-1975-2021·Announced 2021-07-07

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.

What this means for you

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
  • mis-labeling

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

Distributed nationwide across the United States.

Related recalls

Same category