Z-0328-06

Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G

Name: Z-0328-06 Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
Creator: Encore Medical, Lp
Published: 2005-10-21
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2005-10-21 / Terminated

FDA source

Encore Medical, Lp began a recall of Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G on 2005-10-21. The reason FDA records is "Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0328-06
Status: Terminated
Initiated: 2005-10-21
Posted: 2005-12-28
Terminated: 2008-04-16
Recalling firm: Encore Medical, LP
Product: Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.
FDA root cause: Other
Action: The firm initiated the recall on 10/21/05 via letter to all consignees.
Quantity in commerce: 141 units.
Distribution: Device distributed nationwide to direct accounts in AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, MO, MT, NM, NH, NJ, OK, OH, PA, SC, SD, TX, UT, VA, and WA. Foreign distribution to Saudi Arabia, Japan and Germany.
Product codes and lots: Revision G (instrument not tracked by lot number).

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)