Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 2, 2015
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Pega Medical Inc. recalled SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Glidi… - a moderate-severity action.
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Glidi… was recalled by Pega Medical Inc. in December 2, 2015. Reason: SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of t…. Check the official notice for the remedy. Verify recall #Z-0324-2016 with the FDA Devices before acting.
The recall
Pega Medical Inc. issued this moderate-severity FDA Devices recall-SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of t….
- Moderate
- severity level
- 4 units
- affected scope
- Class II
- classification
- December 2, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0324-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0324-2016) was formally reported on December 2, 2015, with the manufacturer initiating the action on October 20, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Pega Medical Inc. is listed as the recalling firm, operating out of Laval, N/A. Federal records list the affected scope as 4 units distributed in the US.
The documented reason for this recall is: SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. Distribution data in the federal record shows the product reached: Distributed in the states of FL and TN.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4 units distributed in the US
Related Recalls
6
3 from same agency
Product description
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
Reason for recall
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0324-2016 |
| Date reported | December 2, 2015 |
| Date initiated | October 20, 2015 |
| Recalling firm | Pega Medical Inc. |
| Firm location | Laval, N/A |
| Affected scope | 4 units distributed in the US |
| Distribution | Distributed in the states of FL and TN. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0324-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.. Recalled by Pega Medical Inc.. Units affected: 4 units distributed in the US.
Why was this product recalled? ▼
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2015. Severity: Moderate. Recall number: Z-0324-2016.
Where was the recalled product distributed? ▼
Distribution: Distributed in the states of FL and TN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0324-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 2, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.