Recall Z-0685-2017— MicroPort Orthopedics Inc.
Class III · Terminated
Class III FDA medical device recall by MicroPort Orthopedics Inc., initiated 2016-06-21, terminated 2017-07-01. It names one FDA 510(k) clearance: K100866. Product: Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head. Reason: 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..
- Recalling firm
- MicroPort Orthopedics Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-06-21
- Terminated
- 2017-07-01
- Firm location
- Arlington, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.