Z-0916-2007

AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog...

Name: Z-0916-2007 AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog...
Creator: Exactech, Inc.
Published: 2006-07-21
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2006-07-21 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44 on 2006-07-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0916-2007
Status: Terminated
Initiated: 2006-07-21
Posted: 2007-06-09
Terminated: 2012-05-06
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.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 6
Distribution: World wide-Domestically distributed to one account in Alabama and internationally to Columbia and Australia.
Product codes and lots: 0797860, 0797861, 0797862, 0797857, 0797858, 0797859

Product code LPH

K993736Class IIExactech Acumatch Integrated Hip System M-Series Femoral Stem ComponentExactech, Inc. / cleared 2000-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)