Z-2497-2019Class II

Caiman Disp.instr.articulat.d:12/440mm Ref: Pl731su-

Name: Z-2497-2019 Caiman Disp.instr.articulat.d:12/440mm Ref: Pl731su-
Creator: Aesculap Implant Systems LLC
Published: 2019-08-07
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2019-08-07 / Terminated / root cause: sterility

FDA source

Aesculap Implant Systems LLC began a recall of CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation... on 2019-08-07. FDA classified it as Class II and gives the reason as "possibility of the sterility batch being insufficiently sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2497-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-07
Posted: 2019-09-09
Terminated: 2020-05-12
Recalling firm: Aesculap Inc
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: possibility of the sterility batch being insufficiently sterilized
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: 1. Immediately examine your inventory and quarantine product. 2. Determine your current inventory of the affected product within your facility. Do not destroy any affected product. 3. Fill out and return the completed "the Medical Device Recall Acknowledgement Response Form " along with the product to the to the address : Aesculap Inc. Attn: Ted Dachroeden 615 Lambert Pointe Drive Hazelwood, MO 63042 4. Please Contact Customer Service for an RGR number and call tag to return your affected product. You will receive credit for your returned product. AIC Customer Service Number 1-800-282-9000 [email protected] 5. If the total inventory in your possession is zero (0), please return the form to: [email protected] Fax: 610-791-6882 If you have any questions, please contact, Josie McBride at (610) 984-9290.
Quantity in commerce: 0
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: Lot # 823B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2497-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2496-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09
Z-2497-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09

Product code GEI

K093075Class IIAragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. / cleared 2010-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)