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.
This recall has been terminated (originally issued June 20, 2011).
- Company
- Ortho Development Corporation
- Recall Initiated
- May 10, 2011
- Posted
- June 20, 2011
- Terminated
- November 9, 2011
- Recall Number
- Z-2602-2011
- Quantity
- 113 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Tests on PVC packaging material resulted in alert levels for cytotoxicity.
Distribution
Nationwide Distribution - USA including CA, FL, and TX.
Lot / Code Info
REF Number 108- 1017, 1019, 1217, 1219, 1221, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827. All Lot numbers.
Root Cause
Package design/selection
Action Taken
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.
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