Z-2321-2020Class II

A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 -

Name: Z-2321-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 -
Creator: Biomet
Published: 2020-05-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-05-14 / Terminated / root cause: design

FDA source

Biomet began a recall of A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and... on 2020-05-14. FDA classified it as Class II and gives the reason as "Distributed to the field without having completed design history files or design transfer activities". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2321-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-14
Posted: 2020-06-09
Terminated: 2021-04-08
Recalling firm: Zimmer GmbH
Product: A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Distributed to the field without having completed design history files or design transfer activities
Root cause tag: design
FDA root cause: Device Design
Action: Zimmmer Biomet issued Urgent Medical Device Recall letter , dated May 14, 2020 to Risk Manger, Distributors,Surgeons, stating reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
Quantity in commerce: 1 US
Distribution: Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
Product codes and lots: Lot Number: All lots expiring prior to December 31, 2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2321-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2303-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2304-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2305-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2306-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2307-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2308-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2309-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2310-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2311-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2312-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2313-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2314-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2315-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2316-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2317-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2318-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2319-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2320-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2321-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2322-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2323-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2324-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09

Product code HRS

K143697Class IIBiomet Proximal Humerus Plating SystemBiomet Manufacturing / cleared 2015-03-30

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)