Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in ...
FDA Device Recall #Z-0793-2016 — Class II — January 11, 2016
Recall Summary
| Recall Number | Z-0793-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 11, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Smith & Nephew, Inc. |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 69043 units |
Product Description
Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.
Reason for Recall
Blade exhibiting fracture during hip arthroscopy procedures
Distribution Pattern
Worldwide distribution. US Nationwide and countries of AT, AU, BE, CA, CH, CL, CN, CZ, DB, DE, DK, EE, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, LT, LV, NL, NO, PL, PR, PT, RO, SE, SG, SI, TH, TR, and ZA.
Lot / Code Information
Lot Codes: ( Devices within Expiry) 3009063 3009559 3010117 3010720 3011688 3012095 3012366 3014560 3016455 3018390 3020194 3022929 3025736 3027818 3030178 3032892 3036529 3071312 3071546 3074279 3074280 3076377 3076427 3085969 3089220 3093258 3098516 3101929 3104300 3107341 3111387 3114657 3115976 3119607 3123832 3124356 3124896 3125448 3128384
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.