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ShurFit CRT Peek Cage

PRECISION SPINE, INC. · Model CRTP10-07 · UDI-DI 00840019908856

JDK Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

CRT Peek 10 degree x 07mm

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.