Acumed Hexalobe Screws
Acumed Hexalob Screws may break during use due to a manufacturing error.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
FDA, reason for recall
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
Acumed Hexalob Screw various sizes
- UDI-DI
- 10806378125997
- 10806378126000
- 10806378126017
- 10806378126024
- 10806378126031
- 10806378126048
- 10806378126055
- 10806378126062
- 10806378126079
- 10806378126086
- 10806378126093
- 10806378126109
- 10806378126116
- 10806378126123
- Lot
- 668261
- 680797
- 667231
- 682194
- 680621
- 680737
- 667233
- 668266
- 668704
- 682195
- 668706
- 680400
- 667236
- 668705
- 680935
- 667237
- 680936
- 668269
- 682390
- 681575
- 667169
- 668260
- 682482
- 667202
- 668271
- 667242
- 668273
- 667205
- 668272
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin.
- Event ID
- 99123
- Recall No.
- Z-2532-2026
- Company
- Acumed LLCHillsboro, Oregon
- Hazard
- Manufacturing deviation
- Quantity recalled
- 5,272 units
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
