FDA Device Recall Z-0012-06: Recall Record

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-06.

Recall Res Number

Z-0012-06

Recalling Firm / Manufacturer

N/A

FEI Number

2242816

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-06-24

Date Posted

2005-10-07

Date Terminated

2006-07-03

Product Code

JDS

Event Number

32813

Product Quantity

102 nails

Product Description EBI Trochanteric 11mm Long Nail.

Reason for Recall Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.

Action Details The firm sent out via e-mail notification to their field representatives on 6/27/2005 to identify, remove and return to EBI all affected product from their inventories. One direct customer, Dr. Maylack was sent a recall letter on 7/7/2005.

Distribution Pattern There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.

Code Information / Serial Numbers Catalog No./Lot Nos: 28226/164522; 28228/164523; 28230/175576; 28234/175583; 28238/175589; 28248/164527; 28324/164529; 28326/164531; 28328/164532; 28330/175614; 28332/170182; 28334/175621; 28338/175630; 28342/166415; 28344/164540; 28348/164545.

Related Establishments / Registrations

SMITH & NEPHEW, INC. Registration: 1020279 View Registration
ONYX MEDICAL LLC Registration: 1043653 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
Orthopedic Designs North America, Inc. Registration: 1064129 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
SMITH & NEPHEW INC. Registration: 1643264 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
ORTHO DEVELOPMENT CORP. Registration: 1722511 View Registration
ZIMMER, INC. Registration: 1822565 View Registration
BIOMET, INC. Registration: 1825034 View Registration
ORCHID UNIQUE Registration: 1828288 View Registration
INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration
PARAGON MEDICAL, INC. Registration: 1834331 View Registration
NGInstruments, Inc dba Avalign Cutting Instruments Registration: 1835251 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
TRIMED, INC. Registration: 2031009 View Registration
ORTHOFIX US LLC Registration: 2183449 View Registration
EBI, LLC Registration: 2242816 View Registration
SCT, INC. Registration: 2249615 View Registration
C & J INDUSTRIES, INC. Registration: 2522206 View Registration
Synthes GMBH Registration: 3000270450 View Registration
SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH Registration: 3002808145 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
ALDEN TOOL COMPANY, INC. Registration: 3003525643 View Registration
T & L SHARPENING, INC. Registration: 3003541440 View Registration
HARWOOD DESIGN, INC. Registration: 3003761012 View Registration
GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration
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I.T.S. GMBH Registration: 3004369035 View Registration
DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration
PURACON GMBH Registration: 3004638532 View Registration
PROCON MEDIZINTECHNIK GMBH Registration: 3005076207 View Registration
MICRO PRECISION SWISS Registration: 3005497913 View Registration
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BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
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MOSER-BAER AG Registration: 3007441485 View Registration
MEDSHAPE, INC. Registration: 3007593722 View Registration
STERIPACK MEDICAL POLAND SP. Z O.O. Registration: 3007766601 View Registration
Changzhou Biomet Medical Devices Co., Ltd. Registration: 3007923096 View Registration
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Smith & Nephew, Inc. Registration: 3008744062 View Registration
LX PRECISION SHANGHAI CO LTD Registration: 3008791302 View Registration
Synthes (USA) Products LLC Registration: 3008812560 View Registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
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Eurofins STERIPAC GMBH Registration: 3009217531 View Registration
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ARCH Medical Solutions - Memphis Registration: 3009973505 View Registration
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LH MEDICAL CORPORATION Registration: 3010057495 View Registration
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Auxein medical Private limited Registration: 3010303097 View Registration
FRUEH VERPACKUNGSTECHNIK AG Registration: 3010363503 View Registration
AXIAL MEDICAL Registration: 3010863450 View Registration
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Zimmer Biomet Taiwan Co., Ltd. Registration: 3011683674 View Registration
ZIMMER PTE. LTD. Registration: 3013176080 View Registration
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3D INSTRUMENTATION SDN BHD Registration: 3014170143 View Registration
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Jabil Switzerland Manufacturing GmbH (Raron) Registration: 3015869121 View Registration
Jabil Switzerland Manufacturing GmbH (Grenchen) Registration: 3015869492 View Registration
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Smith & Nephew, Inc. Registration: 3038503932 View Registration
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FRIEDRICH DANIELS GMBH Registration: 9611390 View Registration
CHRISTIAN DIENER GMBH Registration: 9611813 View Registration
NARANG MEDICAL, LTD. Registration: 9613910 View Registration
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SYNTEC SCIENTIFIC CORP. Registration: 9616944 View Registration
ORTHOFIX SRL Registration: 9680825 View Registration

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Medical Device Recall: Z-0012-06

Recall Parameters & Description

Related Establishments / Registrations

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