Food, drugs, devices › Aesculap Implant Systems LLC
Device recall: RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
FDA enforcement event 90537 is a device recall by Aesculap Implant Systems LLC of Center Valley, PA, initiated 30 Jun 2021 and classified Class II, with 2 product records.
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 17 Apr 2024. Initiation: voluntary: firm initiated. Aesculap Implant Systems LLC has 35 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
Aesculap Implant Systems LLC, Center Valley, PA.
Reason for recall
"Customized coronal rod benders may deform the implant when used with the spinal system devices."
Distribution
"United States: CO"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1405-2022 | RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. | 2 pieces | Class II | Terminated | 27 Jul 2022 |
| Z-1406-2022 | LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. | 2 pieces | Class II | Terminated | 27 Jul 2022 |
Context
Other enforcement events for Aesculap Implant Systems LLC
All 35 events for Aesculap Implant Systems LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Customized coronal rod benders may deform the implant when used with the spinal system devices."
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: "United States: CO"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Apr 2024. "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.