Z-2603-2011

Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper...

Name: Z-2603-2011 Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper...
Creator: Ortho Development Corporation
Published: 2011-05-10
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2011-05-10 / Terminated / root cause: packaging

FDA source

Ortho Development Corporation began a recall of Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. Intended for use in total hip... on 2011-05-10. The reason FDA records is "Tests on PVC packaging material resulted in alert levels for cytotoxicity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2603-2011
Status: Terminated
Initiated: 2011-05-10
Posted: 2011-06-20
Terminated: 2011-11-09
Recalling firm: Ortho Development Corp.
Product: Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone.
Product code: MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Reason for recall: Tests on PVC packaging material resulted in alert levels for cytotoxicity.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Ortho Development Corporation notified consignees by letter on May 11, 2011. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to return all remaining affected units to Ortho. Replacement product was to be shipped by May 31.
Quantity in commerce: 113 units
Distribution: Nationwide Distribution - USA including CA, FL, and TX.
Product codes and lots: REF Number 109-1019, 1217, 1219, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827.All Lot numbers.

Product code MBL

K053293Class IIEncompass 10*17 and 12*17 Extended Press-Fit Hip StemsOrtho Development Corp. / cleared 2006-02-16

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)