Recall Z-0810-2022 ยท JDR Staple, Fixation, Bone
Biomet, Inc.
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
| Date | Feb 14, 2022 |
| Status | Terminated |
| Reason | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part. |
| Root cause | Under Investigation by firm |
| Action | A recall notification was sent via courier 24 Feb 2022 to distributors, surgeons, and hospital risk managers. Customers advised to locate and quarantine product, return to Biomet and identify any further customers receiving product. Recalled product is identified using specific lot and item numbers. Additionally, surgeons and hospital risk managers are to follow any specified patient monitoring instructions and return the Certificate of Acknowledgement to Zimmer Biomet. If you have further questions or concerns, please call customer service at 574-371-3071 or send questions via email to Corpor |
| Quantity | 38 |
| Distribution | Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133939 | MODIFIED DISTAL RADIUS PLATING SYSTEM Biomet, Apr 1, 2014 |