Acuity Surgical Devices recalls

Acuity Surgical Devices has 2 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 17 Jun 2020. 2 are still ongoing. The most frequent reason is potency & assay.

Total recalls2since 2020

Last 12 months0reported

Class I00% of total

Ongoing2latest 17 Jun 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why acuity surgical devices is recalled

Potency & Assay2100%

Product types

Spinal Implants2100%

By year

20202100%

Ongoing acuity surgical devices recalls

2 active

Reported	Class	Recall	Company	Reason	Where
17 Jun 2020Device	CLASS II	A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti recalled	Acuity Surgical Devices	Potency & Assay	Nationwide
17 Jun 2020Device	CLASS II	A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti recalled	Acuity Surgical Devices	Potency & Assay	Nationwide

All acuity surgical devices recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
17 Jun 2020Device	CLASS II	A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti recalled	Acuity Surgical Devices	Potency & Assay	Nationwide
17 Jun 2020Device	CLASS II	A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti recalled	Acuity Surgical Devices	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.