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KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack

MEDTRONIC SOFAMOR DANEK, INC. · Model CX01B · UDI-DI 00643169097797

NDN Prescription

510(k) clearances

4,809

Adverse events (94 deaths)

Recalls

114

Facilities

Description

BONE CEMENT CX01B XPEDE W MIXER US

Recalls

Date	Firm	Reason
2022-12-15	TEKNIMED SAS	Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
2021-05-18	Stryker Spine	The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
2021-05-18	Stryker Spine	The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.