FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: 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.
- Recall number
- Z-2497-2019
- Recalling firm
- Aesculap Implant Systems LLC
- 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.
- Status
- Terminated
- Initiated
- 2019-08-07
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- possibility of the sterility batch being insufficiently sterilized
- 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 Aesculap_Emailorders.BBmus_service@aesculapusa.com 5. If the total inventory in your possession is zero (0), please return the form to: Josie.mcbride@aesculapusa.com Fax: 610-791-6882 If you have any questions, please contact, Josie McBride at (610) 984-9290.
- Quantity
- 0
- Distribution
- US Nationwide distribution in the state of CA.
- Lot, serial or model codes
- Lot # 823B
- 510(k) numbers
- ["K093075"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28