| Class 3 Device Recall Biomet Microfixation, Inc. Obwegeser Ramus Clamp | |
Date Initiated by Firm | May 21, 2008 |
Create Date | June 25, 2015 |
Recall Status1 |
Terminated 3 on September 11, 2009 |
Recall Number | Z-0906-2009 |
Recall Event ID |
50737 |
Product Classification |
Self Retaining Clamp - Product Code EMG
|
Product | Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc., Subsidiary of Biomet Microfixation, Inc. NOTE: None distributed domestically.
Cranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional. The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending ramus of the mandible with an extension on one of the blades (shields) to aid in retracting the soft tissue of the cheek. |
Code Information |
Lot Number 050801. |
Recalling Firm/ Manufacturer |
Biomet Microfixation, Inc. 1520 Tradeport Dr Jacksonville FL 32218-2480
|
For Additional Information Contact | 904-741-4400 |
Manufacturer Reason for Recall | The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Customers were contacted by e-mail notification with read receipt. Customers were notified in the e-mail to immediately discontinue use of the recalled product and return the affected items to Biomet Microfixation, Inc. The e-mail also included an Inventory Reconciliation form for customers to complete and return via fax (904-741-1801) to Biomet Microfixation, Inc. For questions related to this notice, please call 1-800-874-7711 or 904-741-4400 extension 448, Monday through Friday, 8 a.m.-4 p.m. Eastern Standard Time (EST). |
Quantity in Commerce | 4 |
Distribution | International Distribution including countries of Ireland and 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.
|
|
|
|