Home › Medacta International SA › MectaPlug PE II

MectaPlug PE II

Medacta International SA · Model 01.33.203 · UDI-DI 07630345710987

JDK Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

MectaPlug PE II size L

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.....)

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.