Z-2362-2020Class II

Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument

Name: Z-2362-2020 Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument
Creator: Biomet
Published: 2020-05-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-05-01 / Terminated / root cause: manufacturing process

FDA source

Biomet began a recall of Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235 on 2020-05-01. FDA classified it as Class II and gives the reason as "Device and tray that houses the device did not pass steam sterilization process validation testing". 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-2362-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-01
Posted: 2020-06-12
Terminated: 2021-07-28
Recalling firm: Zimmer GmbH
Product: Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Device and tray that houses the device did not pass steam sterilization process validation testing
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Zimmer Biomet issued letter dated 5/1/20 to Distributors,Risk Managers and Surgeons, states reason for recall, health risk and action to take: 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 recall 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 Distributor Responsibilities: Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 1. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
Quantity in commerce: 136 units
Distribution: Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2362-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2362-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-12
Z-2363-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-12

Product code LXH

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)