smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713...

FDA Device Recall #Z-1028-2019 — Class II — February 19, 2019

Recall Summary

Recall Number Z-1028-2019
Classification Class II — Moderate risk
Date Initiated February 19, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Smith & Nephew, Inc.
Location Memphis, TN
Product Type Devices
Quantity 58 units

Product Description

smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510

Reason for Recall

Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

Distribution Pattern

US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain

Lot / Code Information

Batch Numbers: 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035 & 18CM08027

Other Recalls from Smith & Nephew, Inc.

Recall # Classification Product Date
Z-0957-2026 Class II BIOSURE HA SCREW, 6MM x 20 MM. Threaded metalli... Nov 24, 2025
Z-1806-2025 Class II META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, R... Mar 18, 2025
Z-0326-2025 Class II Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI... Oct 15, 2024
Z-3171-2024 Class II DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, me... Jul 9, 2024
Z-3172-2024 Class II DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, me... Jul 9, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.