Medos International Sarl: CEREBASE DA Guide Sheath Recalled for Potential Distal End Fractures

What You Should Do

1. Identify if you have the affected CERENOVUS CEREBASE DA Guide Sheath by checking the part and lot numbers on the product packaging. Affected part numbers include GS9080SD, GS9090SD, and GS9095SD.
2. For part GS9080SD, look for lot numbers: 31121042, 31133636, 31140739, 31140751, 31146719, 31154809, 31160736, 31174927, 31178955, 31189206, 31194710, 31194733, 31208988, 31212653, and 31212661.
3. For part GS9090SD, look for lot numbers: 31094249, 31103843, 31108260, 31116484, 31116485, 31121039, 31121040, 31121043, 31121044, 31133637, 31133638, 31140740, 31140952, 31146720, 31150968, 31150969, 31154810, 31154811, 31160737, 31160738, 31168610, 31168611, 31174928, 31174930, 31178956, 31178957, 31178958, 31189207, 31189208, 31194711, 31194712, 31194734, 31194735, 31204436, 31208989, 31208990, 31208991, 31212654, 31212655, 31212663, and 31225738.
4. For part GS9095SD, look for lot numbers: 31208992 and 31212656.
5. Contact your healthcare provider or the manufacturer, Medos International Sarl, immediately if you possess these devices to receive further instructions on returning the product and obtaining potential refunds.
6. For more information or to report a related issue, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products