Recall record at a glance
| Official record | Z-1975-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | SPINEART SA |
| Report date | Jul 7, 2021 |
| Recall initiation date | Apr 9, 2021 |
| Quantity | 44 units in the U.S. |
| Location | Plan-Les-Ouates, N/A, Switzerland |
Official product description
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
Why the product was recalled
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Distribution information
U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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