Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor...

FDA Device Recall #Z-2418-2015 — Class II — July 29, 2015

Recall Summary

Recall Number Z-2418-2015
Classification Class II — Moderate risk
Date Initiated July 29, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Synthes (USA) Products LLC
Location West Chester, PA
Product Type Devices
Quantity 1113

Product Description

Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.

Reason for Recall

Potential for micropores to form, allowing fluid to enter the hollow handle.

Distribution Pattern

Nationwide and internationally, including Canada

Lot / Code Information

Part Numbers 03.100.013 03.100.014 with lot numbers: 5001180 5001181 5043720 5043721 5043722 5043723 5056224 5056410 5056411 5101097 5106064 5109323 5162016 5207917 5252353 5252354 5303914 5303916 5626912 904732 / A7OA43 908057 / A7PA10 909551 / A7PA20 910819 / A7PA30 T100870 T104992 T108114 T114599 T938508 T939338 T939640 T942069 T945414 T946497 T949375 T954443 T958062 T963371 T968151 T968381 T972086 T974174 T974550 T977901 T980418 T980555 T983069 T984285 T987813 T993091 T996572 T999967 5001182 5001183 5042920 5042921 5042922 5042923 5056851 5087081 5087082 5109324 5109325 5109326 5109327 5162012 5207918 5252394 5256421 5256479 5256480 5305758 5305759 5305760 5877095 6040220 6040225 6040226 6056133 6056134 903786 / A7OA37 904731 / A7OA43 908058 / A7PA10 909552 / A7PA20 910911 / A7PA31 T100871 T104993 T108115 T114598 T932954 T935264 T939339 T945413 T946498 T947785 T954444 T958061 T963372 T968152 T974175 T977904 T980511 T983070 T984228 T987809 T989000 T993092 T996565 T999969

Other Recalls from Synthes (USA) Products LLC

Recall # Classification Product Date
Z-0228-2026 Class II LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM... Sep 26, 2025
Z-0229-2026 Class II LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM... Sep 26, 2025
Z-1916-2024 Class II STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/... Apr 25, 2024
Z-1239-2024 Class II TFNA Femoral Nail 9mm, right, 130¿, L 235mm-In... Jan 24, 2024
Z-1238-2024 Class II RAPIDSORB IPS Battery Pack, Sterile-Intended fo... Jan 24, 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.