ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; F
FDA device recall Z-2695-2016 · posted 2016-09-08 · Terminated
Recall details
- Recalling firm
- MicroPort Orthopedics Inc.
- Reason for recall
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Action taken
- MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to Postmarket@ortho.microport.com. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days. For questions regarding this recall call 901-867-4771.
- Root cause
- Use error
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 110 units
- Distribution
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- Date initiated
- 2016-06-21
- Date posted
- 2016-09-08
- Date terminated
- 2017-07-26
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCE TOTAL KNEE SYSTEM (K061223) | Wrightmedicaltechnologyinc | 2006-08-18 |