Z-2300-2020Class II

Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100...

Name: Z-2300-2020 Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100...
Creator: Biomet, Inc.
Published: 2020-05-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-05-11 / Terminated

FDA source

Biomet, Inc. began a recall of Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503... on 2020-05-11. FDA classified it as Class II and gives the reason as "The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2300-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-11
Posted: 2020-06-09
Terminated: 2020-11-04
Recalling firm: Zimmer GmbH
Product: Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
FDA root cause: Under Investigation by firm
Action: On May 11, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Distributors were asked to return all affected product from their distributorship and from affected hospitals within their territory. Distributors should identify whether there are any additional hospitals that the recalling firm has not notified and provide a list of these additional accounts to Zimmer Biomet. Risk managers at hospitals were asked to take the following actions: 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 recall notice for hospitals and ensure documentation. 4. Complete the Certificate of Acknowledgement and send to [email protected]. This form should 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].
Quantity in commerce: 38
Distribution: US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.
Product codes and lots: Lots 814100, 570640, 728890, 977300

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2300-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2300-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-08

Product code PHX

K152754Class IIComprehensive Vault Reconstruction System (Vrs)Biomet Manufacturing Corp / cleared 2016-05-16

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)