Home › Paragon 28, Inc. › APEX 3D Total Ankle Replacement System
APEX 3D Total Ankle Replacement System
Paragon 28, Inc. · Model P99-153-P105-S · UDI-DI 00889795118448
HAB
Prescription
2
510(k) clearances
9,977
Adverse events (3 deaths)
16
Recalls
55
Facilities
Description
Reciprocating Saw Blade, Blunt Tip, Single Sided 8 x 50mm, 1.0mm, QTY 1, Depuy-Synthes
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-27 | Arthrex, Inc. | The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2016-09-28 | Zimmer Biomet, Inc. | Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is |
| 2015-11-10 | Zimmer, Inc. | The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. |
| 2015-11-10 | Zimmer, Inc. | The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. |
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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.