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Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, a...

FDA Device Recall #Z-1082-2016 — Class II — January 29, 2016

Recall Summary

Recall Number Z-1082-2016
Classification Class II — Moderate risk
Date Initiated January 29, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 21,268

Product Description

Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.

Reason for Recall

Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxidative material would flake off a component contained within the ePAK and enter the surgical field/wound an inflammatory reaction may occur. The inflammatory reaction may result in a foreign body reaction and/or metal hypersensitivity. Oxidized components have failed cytotoxicity testing.

Distribution Pattern

Worldwide distribution: US (Nationwide) and countries of: Panama; Korea; Japan; Netherlands; Ecuador; Chile; Canada; and Australia.

Lot / Code Information

All Lots. Part number: Description: 811810050 DVR EPAK EX NRW LOCK PLT RIGHT 811811040 DVR EPAK NRW MINI LOCK PLT R 811811050 DVR EPAK NRW LOCK PLT R 811812040 DVR EPAK MINI LOCK PLT R 811812050 DVR EPAK DIST VLR PT STD R 811812060 DVR EPAK DISTAL VLR PLT MED RT 811812090 DVR EPAK DISTAL PLT LONG RT 811812125 DVR EPAK EXT LONG LOCK PLT R 811812175 DVR EPAK EX-EXT LONG LK PLT R 811813050 DVR EPAK WIDE LOCK PLT R 811814050 DVR EPAK VOLAR RIM PLATE RIGHT 811815050 DVR EPAK VOLAR RIM NRW PLT RT 811817050 DVR EPAK DORSAL PLATE STD RT 811817150 DVR EPAK DORSAL PLATE WIDE RT 811818060 DVR EPAK RADIAL PLT STD RIGHT 811818160 DVR EPAK RADIAL PLATE WIDE RT 811820050 DVR EPAK EX NRW LOCK PLT LEFT 811821040 DVR EPAK NRW MINI LOCK PLT L 811821050 DVR EPAK NRW LOCK PLT L 811822040 DVR EPAK MINI LOCK PLT L 811822050 DVR EPAK LOCK PLT L 811822060 DVR EPAK MEDIUM LOCK PLT L 811822090 DVR EPAK LONG LOCK PLT L 811822125 DVR EPAK EXT LONG LOCK PLT L 811822175 DVR EPAK EX-EXT LONG LK PLT L 811823050 DVR EPAK WIDE LOCK PLT L 811824050 DVR EPAK VOLAR RIM PLATE LEFT 811825050 DVR EPAK VOLAR RIM NRW PLT LT 811827050 DVR EPAK DORSAL PLATE STD LEFT 811827150 DVR EPAK DORSAL PLATE WIDE LT 811828060 DVR EPAK RADIAL PLATE STD LEFT 811828160 DVR EPAK RADIAL PLATE WIDE LT 811839050 DVR EPAK ULNA PLATE BILATERAL 811899001 DVR EPAK RIGHT DNI 811899002 DVR EPAK LEFT DNI 811899003 EPAK DVR C/LCK VOLR RIM RT DNI 811899004 EPAK DVR C/LCK VOLR RIM LT DNI 811899005 EPAK DVR DORSAL PLATE RT DNI 811899006 EPAK DVR DORSAL PLATE LT DNI 811899007 EPAK DVR RDL COLUMN PLT RT DNI 811899008 EPAK DVR RDL COLUMN PLT LT DNI 811899009 EPAK DVR ULNA PLT BILAT DNI 811911050 DVR EPAK NRW LOCK PEG RT 811912050 DVR EPAK LOCK PEG RT 811913050 DVR EPAK WIDE LOCK PEG RT 811921050 DVR EPAK NRW LOCK PEG LT 811922050 DVR EPAK LOCK PEG LT 811923050 DVR EPAK WIDE LOCK PEG LT 811999001 DVR EPAK PEG RIGHT DNI 811999002 DVR EPAK PEG LEFT DNI

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

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.

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