MicroPort Orthopedics Inc.: Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, R

Is my product affected?

Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF 38024450, REF 38024454, REF

• UPC 10994124810
• UPC 021109196901

Check against the official notice below — it lists the full affected range.

What happened

MicroPort Orthopedics Inc. is recalling approximately 68,199 units of Conserve Shell hip replacement components across multiple reference numbers due to an increasing revision rate trend observed in the company's database from 2009 to present. The recalled products are modular head Metal on Metal total hip arthroplasty systems used in combination with Dynasty metal acetabular liner systems, and the company identified a specific hazard involving suspected tissue reaction to metal debris occurring in over one percent of cases.

The recalled Conserve Shells were distributed worldwide, including throughout the United States and numerous countries across Europe, Asia, South America, Africa, and the Middle East. The specific affected products are identified by reference numbers (REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, and REF 38023642) along with corresponding serial numbers. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kin Quantity: 68,199 units Lot/code info: REF 38021146 Serial Numbers: 02210174, 09217496, 01333507, 02334561, 03336229, 04338462, 05340904, 05341951, 10349882, 11351847, 04460698, 04460243, 06480454, 07488190 REF 38021148 Serial Numbers: 02210175, 05216035, 11228750, 01334562, 02336230, 03338463, 05340563, 05340911, 05341952, 09349879, 10352999, 10352998, 10351848, 01457244, 04460700, 04460699, 06481575, 07488019 REF 38021150 Serial Numbers: 01210176, 02210612, 04216036, 05216626, 07218586, 10230051, 03338616, 03338464, 03336231, 03337220, 05340564, 05340914, 05341953, 09349877, 10353000, 10351849, 12353001, 03460701, 04461613, 04461614, 07487904, 059819773 REF 38021152 Serial Numbers: 01210171, 03210614, 09216037, 11232599, 01334560, 01334563, 03336232, 03337221, 03338465, 05340915, 05341909, 06341954, 07348270, 08348659, 09349871, 09349872, 10351850, 11353002, 11353003, 11355254, 02458854, 03469912, 03469913, 06480452, 07485576, 07487905, 104109633, 09496818, 11496825, 059819775, 059821148 REF 38021154 Serial Numbers: 01210177, 02210611, 02211334, 06218587, 07216038, 07221034, 07222228, 10228749, 12232600, 01334564, 02335957, 02336233, 02337222, 03338466, 04339246, 05340565, 05340916, 07343890, 07341955, 08348653, 09348652, 09349881, 09350565, 10351851, 10353004, 11353005, 11355255, 12356822, 12356821, 02458856, 03460702, 04461615, 04461616, 06482947, 06485577, 07487906, 09496819, 09496826, 104109634 REF 38021156 Serial Numbers: 01210434, 01210187, 03210186, 05216627, 06215011, 07221035, 07219757, 11230053, 013351

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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