| Class 3 Device Recall MIKA Speed Block | |
Date Initiated by Firm | August 15, 2006 |
Date Posted | August 07, 2007 |
Recall Status1 |
Terminated 3 on March 27, 2008 |
Recall Number | Z-1135-2007 |
Recall Event ID |
37878 |
Product Classification |
Orthopedic implant positioning device - Product Code LKH
|
Product | Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Austin, TX 78758. |
Code Information |
M.I.K.A. Surgical Kits: MIKA-05-001, MIKA-05-002, MIKA-05-003, MIKA-05-004, MIKA-05-005, MIKA-05-006, MIKA-05-007, MIKA-05-008, MIKA-05-009, MIKA-05-010, MIKA-05-016, MIKA-05-018, MIKA-05-019, MIKA-05-020, MIKA-05-021, MIKA-05-022, MIKA-05-023, MIKA-05-024, MIKA-05-025, MIKA-05-026, MIKA-05-027, MIKA-05-028, MIKA-05-029, and MIKA-05-030. |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
|
For Additional Information Contact | 512-834-6235 |
Manufacturer Reason for Recall | Complaints received that device used to prepare femur to receive femoral implant would split during surgery. |
FDA Determined Cause 2 | Other |
Action | Firm sent notification letter to consignees on 08/25/2006, along with replacement speedblocks. Consignees asked to trade out old speedblocks with the replacements. |
Quantity in Commerce | 24 units. |
Distribution | Product distributed to direct accounts in USA and one consignee in Japan. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|