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Integra® MemoFix®
Ascension Orthopedics, Inc. · Model MS101715 · UDI-DI 10381780121374
JDR
Prescription
1
510(k) clearances
2,672
Adverse events
37
Recalls
241
Facilities
Description
The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
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.