FDA Medical Device Recalls (openFDA)
Exactech, Inc.: AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44.
- Recall number
- Z-0916-2007
- Recalling firm
- Exactech, Inc.
- Product
- AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44.
- Status
- Terminated
- Initiated
- 2006-07-21
- Posted
- 2007-06-09
- Terminated
- 2012-05-06
- Reason
- The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.
- Root cause
- Other
- Action
- The consignees were contacted by fax and email (dated July 21, 2006) to inform them of the recall requesting return of product
- Quantity
- 6
- Distribution
- World wide-Domestically distributed to one account in Alabama and internationally to Columbia and Australia.
- Lot, serial or model codes
- 0797860, 0797861, 0797862, 0797857, 0797858, 0797859
- 510(k) numbers
- ["K993736"]
- PMA numbers
- not on file
- Product code
- LPH
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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