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MectaPlug PE II
Medacta International SA · Model 01.33.201 · UDI-DI 07630345710963
JDK
Prescription
1
510(k) clearances
98
Adverse events (2 deaths)
12
Recalls
24
Facilities
Description
MectaPlug PE II size S
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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Get your free API keyRead the docsData 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.