DeviceSignal · Recall classified
Arrowhead DE LLC
FDA classified a device recall on 2026-08-14 · Class II · Z-2958-2026
EventRecall classified
Effective2026-08-14
ClassificationClass II
On 2026-08-14 the FDA classified a device recall from Arrowhead DE LLC as Class II. Product: Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530…. Recall Z-2958-2026. The firm initiated it on 2026-06-23. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2958-2026
- Classification
- Class II
- Classified on
- 2026-08-14
- Initiated on
- 2026-06-23
- Firm
- Arrowhead DE LLC
- Reason
- Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
- Product
- Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2958-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
5f821782cba5478ef27bc122ae4d625239ad5aea22f825c4a390e8dda0ce849b- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)