Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA
FDA device recall Z-0685-2017 · posted 2016-12-01 · Terminated
Recall details
- Recalling firm
- MicroPort Orthopedics Inc.
- 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.
- Action taken
- MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or PostMarket@ortho.microport.com. For questions regarding this recall call 901-867-4771.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 500 units
- Distribution
- Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece,
- Date initiated
- 2016-06-21
- Date posted
- 2016-12-01
- Date terminated
- 2017-07-01
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROFEMUR HIP SYSTEM MODULAR NECKS (K100866) | Wrightmedicaltechnologyinc | 2010-04-28 |