Aesculap Implant Systems LLC 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

possibility of the sterility batch being insufficiently sterilized

Recommended Action

Per FDA guidance

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.