Recalls / —
—#51535
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.
- FDA product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K993736
- Affected lot / code info
- 0797860, 0797861, 0797862, 0797857, 0797858, 0797859
Why it was recalled
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 (FDA determination)
Other
Action the firm took
The consignees were contacted by fax and email (dated July 21, 2006) to inform them of the recall requesting return of product
Recalling firm
- Firm
- Exactech, Inc.
- Address
- 2320 NW 66th Ct, Gainesville, Florida 32653-1630
Distribution
- Distribution pattern
- World wide-Domestically distributed to one account in Alabama and internationally to Columbia and Australia.
Timeline
- Recall initiated
- 2006-07-21
- Posted by FDA
- 2007-06-09
- Terminated
- 2012-05-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #51535. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.