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Caliber Intramedullary Fixation System

NVision Biomedical Technologies, Inc. · Model CLN-1000T-DPG1 · UDI-DI 00810135963091

MDM Prescription

510(k) clearances

4,185

Adverse events (4 deaths)

Recalls

847

Facilities

Description

Caliber Depth Gauge The Caliber Intramedullary Fixation System is an intramedullary bone fixation screw system used to repair an acute fracture, mal-union or non-union of the clavicle. The intramedullary implant consists of a cannulated screw with distal and proximal threads, a cross-screw receiving hole and a screw head. The diameter ranges from 4.5mm to 5.0mm in lengths from 50mm to 120mm.

Recalls

Date	Firm	Reason
2026-09-07	Healthmark Industries Co., Inc.	Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
2025-03-03	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2024-01-31	Technicality Inc.	The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
2024-01-30	Applied Medical Resources Corp	Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
2024-01-30	Applied Medical Resources Corp	Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
2022-11-17	MEDLINE INDUSTRIES, LP - Northfield	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
2022-11-08	ENDO Pharmaceuticals Solutions, Inc.	No expiration dates printed on the packaging
2022-11-02	Arthrex, Inc.	The devices may be packaged with the wrong reamer size.

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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.