Recall Z-2116-2009
Ebi, L.P. · initiated March 27, 2009
Product
Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.
Codes / lots: Catalog number: 33-345532; Lot number 598990
Reason for recall
Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
FDA-determined cause: Nonconforming Material/Component
Action taken
Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.
Details
- Recall number
- Z-2116-2009
- Initiated
- March 27, 2009
- Posted by FDA
- September 21, 2009
- Terminated
- September 23, 2009
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 5
- Distribution
- Worldwide Distribution -- USA and Spain.
- Recalling firm
- Ebi, L.P., Parsippany, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2115-2009 | Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems…Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices. | 03/27/2009Terminated |