MicroPort Orthopedics Inc.: Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38B

Is my product affected?

Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF 38BF5460SP, REF 38BF5662, REF

• UPC 14335181454410
• UPC 14335181454409

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

What happened

MicroPort Orthopedics Inc. is recalling approximately 68,221 units of Conserve Cup hip implants used in metal-on-metal total hip replacement systems. The recall was initiated because data from the company's database showed an increasing revision rate trend from 2009 to the present, and the company identified a specific hazard of suspected tissue reaction to metal debris occurring in over one percent of cases involving modular head Conserve systems and Dynasty metal acetabular liner systems.

The recalled products were distributed worldwide, including throughout the United States and numerous countries in Europe, Asia, South America, Africa, and the Middle East. The affected products include multiple reference numbers (REF 38BF3642 through REF 38BF5460 and their SP variants) with specific serial numbers identified for each model. The recall record does not specify a remedy 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: 68,221 units Lot/code info: REF 38BF3642 Serial Numbers: 1380112, 1399025, 1402166, 1340677, 1427276, 1429743 REF 38BF3642SP Serial Number 1416590 REF 38BF3844 Serial Numbers: 1368260, 1402167, 1399026, 1380113, 1418795 REF 38BF3844SP Serial Number 1416814 REF 38BF4046 Serial Numbers: 1368261, 1380114, 1402168, 1399027, 1418796, 1429744, 1449113 REF 38BF4046SP Serial Number 1416950 REF 38BF4248 Serial Numbers: 1397139, 1368262, 1381417, 1399029, 1422026, 1418797, 1433514, 1449114, 1452995 REF 38BF4248SP Serial Number 1416816 REF 38BF4450 Serial Numbers: 1380115, 1399031, 1399231, 1373711, 1366654, 1418948, 1433515, 1431187, 1449115, 1482461, 1484998 REF 38BF4450SP Serial number 1416563 REF 38BF4652 Serial Numbers: 1380116, 1395709, 1368263, 1373712, 1399233, 1427277, 1429745, 1433516, 1445264, 1449116, 1460186, 1460187, 1482463, 1481980 REF 38BF4652SP Serial Numbers: 1417403, 1417616 REF 38BF4854 Serial Numbers: 1381418, 1399234, 1373904, 1368264, 1399235, 1427278, 1431188, 1433517, 1445265, 1460189, 1460188, 1468891, 1481979, 1484999 REF 38BF5056 Serial Numbers: 1381419, 1399236, 1373905, 1368265, 1397140, 1402169, 1413708, 1427279, 1445266, 1449117, 1452997, 1468892, 1468893, 1476014, 1476013, 1482462, 1571773, 1571772, 1650637, 1650638, 1651368 REF 38BF5258 Serial Numbers: 1397141, 1399237, 1368266, 1380117, 1422025, 1431189, 1445267, 1449118, 1452996, 1468894, 1476016, 1482460, 1481456, 1571771, 1571770, 1589362, 1650639 REF 38BF5258SP Serial numbers: 1416945 REF 38BF5460 Serial Numbers: 1368267, 13

Source

Official record: FDA (Device enforcement) ↗

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

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