FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
- Recall number
- Z-1459-2015
- Recalling firm
- Exactech, Inc.
- Product
- Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
- Status
- Terminated
- Initiated
- 2015-02-13
- Posted
- 2015-04-20
- Terminated
- 2016-09-29
- Reason
- Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
- Root cause
- Labeling mix-ups
- Action
- Exactech Agents sent a Product Recall Advisory Notice dated February 12, 2015 by mailed to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Recall Inventory Respponse form and return it to Exactech, per the instructions provided on the notice.
- Quantity
- 112 devices
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.
- Lot, serial or model codes
- Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.
- 510(k) numbers
- ["K042021"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28