Z-0811-2022Class II

BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a...

Name: Z-0811-2022 BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a...
Creator: Biomet, Inc.
Published: 2022-02-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2022-02-14 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of 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... on 2022-02-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0811-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-14
Posted: 2022-03-18
Terminated: 2024-09-30
Recalling firm: Zimmer GmbH
Product: 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.
Product code: JDR Staple, Fixation, Bone
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.
Root cause tag: packaging
FDA 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 [email protected]
Quantity in commerce: 12
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
Product codes and lots: Lot # 913430, UDI:(01)00887868445897(17)310616(10)913430

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0811-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0809-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-18
Z-0810-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-18
Z-0811-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-18
Z-0812-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-18

Product code JDR

K111663Class IITrauma Internal Fixation SystemsDePuy Orthopaedics, Inc. / cleared 2012-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)