Z-1220-2026Class II

BEAR Implant. Model Number: 1000

Name: Z-1220-2026 BEAR Implant. Model Number: 1000
Creator: Miach Orthopaedics
Published: 2025-12-31
License: https://open.fda.gov/license/

Miach Orthopaedics / initiated 2025-12-31 / Open, Classified / root cause: manufacturing process

FDA source

Miach Orthopaedics began a recall of BEAR Implant. Model Number: 1000 on 2025-12-31. FDA classified it as Class II and gives the reason as "Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1220-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-31
Posted: 2026-01-29
Recalling firm: Miach Orthopaedics
Product: BEAR Implant. Model Number: 1000.
Product code: QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Reason for recall: Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Notification to Sales Representatives and consignees began on about 12/31/2025 via email and letter titled URGENT MEDICAL DEVICE RECALL NOTIFICATION. Consignees were instructed to identify and quarantine all unused inventory of the affected lot, discontinue distribution of the affected lot, return all unused affected product, and complete and return the provided Recall Acknowledgement Form. Additionally, consignees were requested to notify customers if the affected lot was further distributed.
Quantity in commerce: 284 units
Distribution: US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI.
Product codes and lots: Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1220-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1220-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29

Product code QNI

K243578Class IIBEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc. / cleared 2025-03-06

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)