Reported Dec 7, 2016 · Terminated
Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF…
MicroPort Orthopedics Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MicroPort Orthopedics Inc. · 5677 Airline Rd · Arlington, TN · 38002-9501
Is this the product you have?
- Lineage LinersREF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
- Lot codes and dates
- REF 70102846 Serial numbers
105 of 105 codes
062173340621733506217336072188791022955512339970123423780934526211356669034596890346075705478476064878450949106011497839114131987025179937035198678035199154075211008085258159095267627085267672125294335016302354026317823026322014056332874056340972066346343066347890066349011076361472086364785086365941086365942086366614027403696027405367037417244037417245037423200047423201057426382057436510067442040067445874067447459077449134077456252077456253077458343087458991097465277097465278107473197097476410107481165107485823107486701
- REF 70202852 Serial Numbers
062173380344227303457113094103603114115155114131988067444763097458085117501995018507062078595474022A147720
- REF 70202852 Serial Numbers
201 of 201 codes
022A147721022A147722022A147723022A147723022A147724062173400421734104217342042173430421888005218881042188820822565008227481082274821022874411228846033346110533514003339967033399680834227409345234083452351034986710349868103498690345565103457114034607580547847506487846084910610849784008499658094103604114115156114131989015140898015145854015167730025182498025182499025185569035198684055208762055228595055229916065242431075242432065245652085258160095267361095267673085267674105281165115291529125292876115292878016311871
- REF 70302858 Serial Numbers
042173391022874209491063056340187106369767106373887
- REF 70303258 Serial Numbers
67 of 67 codes
022A147725022A147726022A147727022A14773904217344042173450421734608225648082256480822748310228741102305880533513911339972034498700346075905478477064878470849106208497841114131990114131991015155783LLALMD033E07520876608525816112529433401630802305633374006634720608636478411636689811638278703741754404742088905743186005743651206744587606744745807745155609745836109747590610748116911748117010748902612750033211750033312750033401850706702853398309862546010871600302975306707982895806984328802010446970401085943040109247404010924750401106375
- REF 70402864 Serial numbers
11228743056339647066347891
- REF 70403264 Serial numbers
08228131056330591
- REF 70403664 Serial Numbers
062A147184062A147738062173480933997111355652034571150346076105478478015140899055199111075241210016303424
- REF 70102846 Serial numbers
- Amount recalled
- 5,009 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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