Z-0082-2021Class II

Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050

Name: Z-0082-2021 Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
Creator: Biomet, Inc.
Published: 2020-09-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-09-04 / Terminated / root cause: sterility

FDA source

Biomet, Inc. began a recall of Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050 on 2020-09-04. FDA classified it as Class II and gives the reason as "Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized". 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-0082-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-04
Posted: 2020-10-08
Terminated: 2021-08-31
Recalling firm: Zimmer GmbH
Product: Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
Product code: N/A
Reason for recall: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Root cause tag: sterility
FDA root cause: Process change control
Action: Zimmer Biomet notified on 9/2/20 Distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory, as well as hospitals that have consumed products in the past 12 months will be notified via FedEx. Surgeons that have consumed products with in the past 12 months notified via FedEx. 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. 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. 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 ha
Quantity in commerce: 80 units US
Distribution: Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
Product codes and lots: Lot Numbers: 868570A 868670A 869650A 869710B 869770A 880720B 926610B 941910A 868570B 868670B 869650B 869720A 869770B 880730A 926620A 941910B 868590A 868680A 869660A 869720B 869780B 880730B 926620B 941920A 868610A 868680B 869660B 869730A 869790B 926570A 926630A 941920B 868610B 868690A 869680B 869730B 880610B 926570B 926630B 941930B 868640A 868690B 869690A 869740A 880700A 926580B 926640A 942010B 868650A 868700A 869690B 869740B 880710A 926590A 926640B 942030B 868650B 868700B 869700A 869750A 880710B 926600A 941900A 942040A 868660A 868710A 869700B 869750B 880720A 926610A 941900B 942040B 868660B 868710B 869710A 869760B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0082-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0081-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0082-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0083-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0084-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)