Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis compo
FDA device recall Z-1948-2015 · posted 2015-07-01 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- 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.
- Action taken
- 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. through 8 p.m. ET.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 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.
- Date initiated
- 2014-10-02
- Date posted
- 2015-07-01
- Date terminated
- 2015-07-01
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NATURAL-KNEE II CONSTRAINED KNEE SYSTEM (K973412) | Sulzer Orthopedics, Inc. | 1997-12-08 |