Recall Z-0423-2015
Zimmer, Inc. · initiated October 14, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Codes / lots: Item 00-5953-056-00; all lots
Reason for recall
To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.
FDA-determined cause: Labeling design
Action taken
On 10/14/2014, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected distributors and hospital Risk Managers. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call the customer call center at 1-877-946-2761.
Details
- Recall number
- Z-0423-2015
- Initiated
- October 14, 2014
- Posted by FDA
- November 24, 2014
- Terminated
- June 9, 2015
- Product code
- HWA – Impactor
- Quantity
- 1165 units
- Distribution
- Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Iceland…
- Recalling firm
- Zimmer, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0424-2015 Class II | Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor…To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial… | 10/14/2014Terminated |