Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 0000
FDA device recall Z-1286-2012 · posted 2012-03-23 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, LLC
- Reason for recall
- On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly.
- Action taken
- Biomet Microfixation, LLC sent an Urgent Medical Device Safety Alert letter dated April 21, 2010 to all consignees affected. Each consignee was notified by E-mail, letter or telephone call the week of April 26, 2010. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to fill out the attached Inventory Reconciliation sheet and FAX it to the attention of the Global Complaint Coordinator at 904-741-9425. If the affected product have been further distribute, consignees are instructed to notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field action notices. For questions contact Christy Cain at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 23
- Distribution
- USA Nationwide Distribution including the states of: California and Texas.
- Date initiated
- 2010-04-26
- Date posted
- 2012-03-23
- Date terminated
- 2012-04-18
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM (K953385) | Walter Lorenz Surgical, Inc. | 1995-09-28 |