Recall Z-0721-2018 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Zimmer Biomet, Inc.
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and re
| Date | Aug 1, 2017 |
| Status | Terminated |
| Reason | The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. |
| Root cause | Package design/selection |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL"-Lot Specific letter dated 8/1/2017 to its Customers via email and/or FedEx. The letter describes the product, problem and actions to be taken. The Instructions to Distributors, Sales Representatives, and Distributor Operation Managers included to ensure affected team member are aware of the contents of the notification letter, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to: corporatequality.postmarket@zimmerbiomet.com., return all |
| Quantity | 3,350 units total |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070978 | ZIMMER SEGMENTAL SYSTEM Zimmer, Inc., Jul 3, 2007 |