FDA Device recall Z-2497-2019
CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedur…
- FDA Device
- Class II
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class II recall of CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedur… by Aesculap Implant Systems, citing possibility of the sterility batch being insufficiently sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2497-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-07 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
Product
CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Reason
possibility of the sterility batch being insufficiently sterilized
Identifiers
| code_info | Lot # 823B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2497-2019%22
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