Z-1750-2020Class II

Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 -

Name: Z-1750-2020 Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 -
Creator: Biomet, Inc.
Published: 2020-03-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-03-13 / Terminated / root cause: sterility

FDA source

Biomet, Inc. began a recall of Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain... on 2020-03-13. FDA classified it as Class II and gives the reason as "There were unknown bioburden levels prior to sterilization, which may affect sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1750-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-13
Posted: 2020-04-20
Terminated: 2021-07-21
Recalling firm: Zimmer GmbH
Product: Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: URGENT MEDICAL DEVICE RECALL notification letters dated 3/13/20 were sent to customers. Risk Manager Responsibilities: 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. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. 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. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 6. 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. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. 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, Mon
Quantity in commerce: 125
Distribution: Worldwide distribution - US Nationwide distribution including the states of AL, CO, KS, MA, MD, MI, MO, NH, NJ, and PA. The countries of Australia, Canada, India, and Netherlands.
Product codes and lots: Lot Numbers: 494350 494350R 233080 364910 489000 079630 516230 742760 362370 465800 197900 175110 175100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1750-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1750-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-20

Product code PHX

K080642Class IIComprehensive Reverse ShoulderBiomet, Inc. / cleared 2008-07-09

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