Z-0630-2021Class II

Titanium IFS, Item number 909680 -

Name: Z-0630-2021 Titanium IFS, Item number 909680 -
Creator: Biomet, Inc.
Published: 2020-11-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-11-25 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation on 2020-11-25. FDA classified it as Class II and gives the reason as "Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0630-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-25
Posted: 2020-12-17
Terminated: 2024-05-08
Recalling firm: Zimmer GmbH
Product: Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 25, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the potential loss of sterility in affected devices. Customers were asked to do the following: 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. 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. All customers should also complete the certificate of acknowledgement included with the letter and return to the firm. 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: 7428
Distribution: Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Product codes and lots: Lot 750930

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0630-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0616-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0617-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0618-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0619-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0620-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0621-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0622-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0623-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0624-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0625-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0626-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0627-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0628-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0629-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0630-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17
Z-0631-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17

Product code MBI

K934469Class IIArthrotek Interference ScrewBiomet, Inc. / cleared 1994-02-23

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)