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FOCUS

NVision Biomedical Technologies, Inc. · Model PD-1000T-110 · UDI-DI 00814008029822

MDM Prescription

510(k) clearances

4,185

Adverse events (4 deaths)

Recalls

847

Facilities

Description

Tower Dis-Engage Instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.

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.