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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
Recall Number Z-1981-2013
Classification Class II
Code Info 25621400 203600 25711600 203800 25621300 25621500 203700 206500 26601000 60025547 25003900 60016485 60028037 60028040 60028041 60028042 60016492 60028045 60016487 60028036 60028038 60028039 60028043 60034329 60034330 60039203 60038245 60043146 60039161 60039170 60039173 25209700 60039184 60039186 60039201 60039207 60016491 60028044 60039214 60039217 60039218 60039220 60039222 60039223 60039224 60034328 60039158 60039199 60039216 223900 365036 365034 365037 60016497 60039221 60043147 60039166 60039168 60039182 60039183 60039209 60039219 60057784 60039213 60063014 60064868 60063150 60064885 60057785 60064862 60064867 60064886 60064888 60063042 60076067 60076073 60079812 60064887 60083643 60076089 60095965 60095967 60096024 60095966 60095988 60095986 60095978 60095989 60118708 365491 365488 365452 365495 365487 365455 365468 365460 365459 60096023 365469 365610 365470 365609 365476 365473 365483 365611 60187598 365608 60233503 366219 60278488 60293376 60301903 60301909 60301910 366367 366361 60293345 366362 366366 366371 366365 366359 366370 60335336 366368 60335394 366364 60331363 366369 366360 366440 60370153 366363 60323737 60441602 60459779 60501809 60506751 60553757 60532130 60609997 60610068 60506791 60717634 60717637 60717636 60750867 60750869 60823726 60834952 60845453 60933807 60940767 60979560 60990032 60659033 61199167 61496604 61501406 61582442 61582445 61582447 61582449 61582444 61599941 61496594 61658306 60750868 369883 61748928 61783682 61748929 61783684 61815823 61817989 61859934 61927043 61938355 61964729 62051548 62211964 62200345 62200346 62197219 62278696 62258850 62273053 62330362 62330364 62322473 62330365
Product Distributed Qty 1,710 units are in distribution
Reason For Recall Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which consists of an inner and outer sterile tray, did not pass the established requirements for seal integrity and seal strength. Specifically, there was approximately 2% of either the inner or outer tray that did not pass the established requirements for seal integrity and seal strength.

Event Detail

Event Id 65833
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada, Mexico, Arab Emirates, Saudi Arabia, and Hong Kong.
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