BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. 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.
FDA Recall Z-0811-2022 · Posted None
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDR
Date Initiated2022-02-14
Date Terminated2024-09-30
Product Quantity12
Reason for Recall
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.
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 [email protected]
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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