CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report

BEAR Implant recalled by Miach Orthopaedics

Miach Orthopaedics is recalling BEAR Implant, distributed nationwide in the US. The recall was initiated on 31 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.

Quantity recalled284 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1220-2026
FDA event ID: 98280
Recalling firm: Miach Orthopaedics, Westborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Dec 2025
FDA classified: 29 Jan 2026
Reported: 4 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

31 Dec 2025	Recall initiated by company
29 Jan 2026	Classified by FDA	+29 days
4 Feb 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

BEAR Implant. Model Number: 1000.

Where it was distributed

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.

Nationwide Alaska California Colorado Connecticut Florida Georgia Illinois Massachusetts Maryland Maine Michigan Minnesota Missouri North Carolina New Jersey New York Ohio Oregon Texas Virginia

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Miach Orthopaedics

All 2

Reported	Class	Recall	Company	Reason	Where
19 Nov 2025Device	CLASS II	BEAR Implant (Bridge-Enhanced ACL Restoration) recalled	Miach Orthopaedics	Other	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide