CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
FDA Recall Z-2496-2019 · Posted None
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Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeGEI
Date Initiated2019-08-07
Date Terminated2020-05-12
Product Quantity3 unit of Lot 837B
Reason for Recall
possibility of the sterility batch being insufficiently sterilized
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
US Nationwide distribution in the state of CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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