Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-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.
FDA Recall Z-2602-2011 · Posted 2011-06-20
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Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Product CodeMBL
Date Initiated2011-05-10
Date Terminated2011-11-09
Product Quantity113 units
Reason for Recall
Tests on PVC packaging material resulted in alert levels for cytotoxicity.
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
Nationwide Distribution - USA including CA, FL, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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