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Cemex Prep Kit

TECRES SPA · Model KIT-01 · UDI-DI 28031497000323

JDK Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

Cemex Prep kit is intended to be used for helping the surgeons during the fixation of artificial joint prostheses with the acrylic bone cement. The device contains a number of accessories useful during a prosthesis implantation surgery performed using the cementing technique. The components are packaged all together in a unique sterile package single-use.

Recalls

Date	Firm	Reason
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2011-01-27	Depuy Orthopaedics, Inc.	The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterilit
2011-01-27	Depuy Orthopaedics, Inc.	The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterilit
2011-01-27	Depuy Orthopaedics, Inc.	The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterilit
2011-01-27	Depuy Orthopaedics, Inc.	The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterilit
2011-01-27	Depuy Orthopaedics, Inc.	The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterilit
2007-09-19	Encore Medical, Lp	Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
2007-09-19	Encore Medical, Lp	Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
2007-09-19	Encore Medical, Lp	Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
2007-09-19	Encore Medical, Lp	Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)

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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.