Recall Z-0514-2015
Biomet Microfixation, LLC · initiated October 17, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Codes / lots: Model 24-6651TI, Lot #s: 472560A, 472560B, 472570A, 518520A, 518520B, 472570B.
Reason for recall
Laser etching on the parts is wider and deeper than the conditions previously validated.
FDA-determined cause: Software Design Change
Action taken
BIOMET sent an Urgent Medical Device Recall letter dated October 17, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following steps: 1) Immediately locate and remove from circulation the items invoiced/consigned/loaned to your account. 2) Carefully follow the instructions on the enclosed "Response Form." and 3)If you have further distributed these items to medical facilities, you must notify them of this action. For questions customers were instructed to call 1-800-874-7711 or 904-741-4400, extension 9448, Monday through Friday, 8 a.m. to 4 p.m. EST. For questions regarding this recall call 904-741-9448.
Details
- Recall number
- Z-0514-2015
- Initiated
- October 17, 2014
- Posted by FDA
- December 16, 2014
- Terminated
- January 4, 2017
- Product code
- LZD – Joint, Temporomandibular, Implant
- Quantity
- 42
- Distribution
- Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
- Recalling firm
- Biomet Microfixation, LLC, Jacksonville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0509-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti MandLaser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0510-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0511-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0512-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0513-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0515-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0516-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0517-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0518-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0519-2015 Class II | Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0520-2015 Class II | Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0521-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0522-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |