Large UNI-CLIP
NEWDEAL · Model 314827SND · UDI-DI 10381780052814
JDR
Prescription
1
510(k) clearances
2,692
Adverse events
37
Recalls
242
Facilities
Description
The LARGE UNI-CLIP STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of size (20mm or 25mm interaxis and lengths vary from 20 to 32mm). The LARGE UNI-CLIP STAPLE is made from Stainless Steel and it is indicated for fixation of bone fractures or for bone reconstruction. It is delivered sterile.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-15 | F & A Foundation | Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. |
| 2026-05-11 | In2bones USA, LLC | Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster |
| 2022-08-30 | Synthes (USA) Products LLC | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larg |
| 2022-03-10 | Wright Medical Technology, Inc. | The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. |
| 2022-02-14 | Biomet, Inc. | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgic |
| 2022-02-14 | Biomet, Inc. | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgic |
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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.