Food, drugs, devices › SPINEART SA
Device recall: PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle
FDA enforcement event 87971 is a device recall by SPINEART SA of Plan-Les-Ouates, N/A, initiated 9 Apr 2021 and classified Class II, with 1 product record.
FDA defines Class II as 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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 29 Sep 2022. Initiation: voluntary: firm initiated. SPINEART SA has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SPINEART SA, Plan-Les-Ouates, N/A, Switzerland.
Reason for recall
"Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size."
Distribution
"U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1975-2021 | 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 | 44 units in the U.S. | Class II | Terminated | 7 Jul 2021 |
Context
Other enforcement events for SPINEART SA
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Jun 2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Sof | Device | Class II | 2 |
| 15 Mar 2024 | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS | Device | Class II | 1 |
| 16 Mar 2023 | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, J | Device | Class II | 1 |
| 5 Feb 2019 | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures | Device | Class III | 1 |
| 27 Nov 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate An | Device | Class II | 7 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Sep 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.