SOLUSTAPLE
NEWDEAL · Model 114002ND · UDI-DI 10381780052364
JDR
Prescription
1
510(k) clearances
2,692
Adverse events
37
Recalls
242
Facilities
Description
The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, after possible treatment of the second ray, to recreate a square or Greek foot. Two types of staples are available (90 or 116 degrees interaxis). In order to safeguard the function of the joint, the staple with oblique design will be used. It is made out of stainless steel, and it is delivered non 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.