Home › Smith & Nephew, Inc. › TWINFIX
TWINFIX
Smith & Nephew, Inc. · Model 72201708 · UDI-DI 03596010605191
HAB
Prescription
2
510(k) clearances
9,977
Adverse events (3 deaths)
16
Recalls
55
Facilities
Description
TWINFIX ULTRA 5.5 MM SPADE TIP DRILL FOR USE WITH 6.5 MM ANCHOR HOLE PREPARATION DEVICE FOR HARD BONE
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. |
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 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.