Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO Surgical, Corp. Th
FDA device recall Z-0915-2009 · posted 2009-02-11 · Terminated
Recall details
- Recalling firm
- Mako Surgical Corporation
- Reason for recall
- The product in its current state may fail during use, which would cause the instrument to be in-accurate.
- Action taken
- A MAKO employee will visually verify product at each account for any product affected by this recall. In addition, a recall letter dated July 1, 2008 was mailed to users (surgeon and owner of system, e.g. hospital). Customers were instructed to complete the enclosed Acknowledgement form and return it to your Clinical Technical Specialist (CTS) or in the enclosed pre-paid addressed envelope to the Mako Surgical Corporation. Please direct questions to your CTS or call 954-927-2044, extension 604.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 44
- Distribution
- Nationwide Distribution USA including states of FL, NY, CA, TX, GA, TN, NC and PA.
- Date initiated
- 2008-05-02
- Date posted
- 2009-02-11
- Date terminated
- 2009-08-21
- Location
- Davie, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) (K072806) | Mako Surgical Corp. | 2008-01-24 |