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Cement Restrictor

TECRES SPA · Model TPA-18 · UDI-DI 08031497001401

JDK Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device. Cement Restrictor is provided with the related inserter.

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.