PASS LP B02317540ZRecalls & reported problems

Medicrea International · SHORT POST DUAL LEAD PEDICLE SCREW Ø7.5 mm x 40 mm + BREAK AWAY NUT (X2) · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Jul 12, 2023Open, Classified
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Z-2458-2023 · Root cause: Under Investigation by firm · FDA record ↗

Device details

UDI-DI	`03613720185598`
Brand	PASS LP
Model	B02317540Z
Company	Medicrea International
Product code	NKB · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jul 2, 2025

Device type (GMDN): Bone-screw internal spinal fixation system, sterile

An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

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EXPEDIUM VERSE 199721001S
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All Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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