Class II — SPINEART SA
| Recalling firm | SPINEART SA |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size. |
| 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 |
| Quantity | 44 units in the U.S. |
| Distribution | U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided |
| Initiated | 2021-04-09 |
| Classified | 2021-06-28 |
| Terminated | 2022-09-29 |
| Recall number | Z-1975-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SPINEART SA (Z-1975-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87971/
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