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UNI-CLIP

NEWDEAL · Model LGUNICPINST · UDI-DI 10381780064435

JDR Prescription
1
510(k) clearances
2,672
Adverse events
36
Recalls
240
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. The Large Uni-Clip Staple is indicated for fixation of bone fractures or for bone reconstruction. The set includes the staples and instruments.

Recalls

DateFirmReason
2026-05-11In2bones USA, LLCDue to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
2022-09-27Synthes (USA) Products LLCThe 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
2022-09-27Synthes (USA) Products LLCThe 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
2022-09-27Synthes (USA) Products LLCThe 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
2022-09-27Synthes (USA) Products LLCThe 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
2022-08-30Synthes (USA) Products LLCDrill 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
2022-03-10Wright Medical Technology, Inc.The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
2022-02-14Biomet, 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
2022-02-14Biomet, 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
2022-02-14Biomet, 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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Data 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.