14mm Distraction Pin 301.914S1Recalls & reported problems

Folsom Metal Products, Inc. · 14mm Distraction Pin · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

3 open recalls name 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: 3

Summary

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

3 FDA recall records name this device's identifier, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Aug 21, 2025Class IIOpen, Classified
Labeling includes shelf life that has not been validated.
Z-2580-2025 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Aug 21, 2025Class IIOpen, Classified
Labeling includes shelf life that has not been validated.
Z-2579-2025 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Aug 21, 2025Class IIOpen, Classified
Labeling includes shelf life that has not been validated.
Z-2578-2025 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

Device details

UDI-DI	`00850014548032`
Brand	14mm Distraction Pin
Model	301.914S1
Company	Folsom Metal Products, Inc.
Product code	GCZ · Retainer, Surgical
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 2, 2023

Device type (GMDN): Intraoperative orthopaedic bone pin/screw, single-use

A small rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) and/or implantable device (e.g., fixation plate) to the bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments/devices. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.

Other Retainer, Surgical devices

12mm Distraction Pin 301.912S1
Folsom Metal Products, Inc. · Retainer, Surgical
1 recall0 reports
12mm Distraction Pin-Double 301.912S2
Folsom Metal Products, Inc. · Retainer, Surgical
1 recall0 reports

All Retainer, Surgical 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 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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