Recall Z-1948-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
| Date | Jul 1, 2015 (initiated Oct 2, 2014) |
| Status | Terminated |
| Reason | Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection. |
| Root cause | Package design/selection |
| Action | On 10/2/2014, URGENT MEDICAL DEVICE RECALL 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, and consignee responsibilities. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759. Hours of operation are Monday through Friday, 8 a.m. throu |
| Quantity | 352 |
| Distribution | US Nationwide Distribution, including DC and the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MT, NC, ND, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973412 | NATURAL-KNEE II CONSTRAINED KNEE SYSTEM Sulzer Orthopedics, Inc., Dec 8, 1997 |