Recall Z-1986-2011 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Inc.
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER, REF 00-5901-040-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
| Date | Apr 14, 2011 (initiated Mar 14, 2011) |
| Status | Terminated |
| Reason | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery. |
| Root cause | Device Design |
| Action | The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Instructions for Handling of Affected Product: 1) Stop using the devices and to quarantine immediately 2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder 3)Ensure they |
| Quantity | 320 |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Germany, Japan, New Delphi and Singapore. Addendum: Finland, Switzerland, UK, Denmark, Spain, Portugal, France, Netherlands, Italy, South Africa, Norway, Spain, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031061 | NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS Zimmer, Inc., Oct 9, 2003 |