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U.S. Department of Health and Human Services

Class 2 Device Recall Encompass Hip Stem, Plasma Spray

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  Class 2 Device Recall Encompass Hip Stem, Plasma Spray see related information
Date Initiated by Firm May 10, 2011
Date Posted June 20, 2011
Recall Status1 Terminated 3 on November 09, 2011
Recall Number Z-2602-2011
Recall Event ID 58763
510(K)Number K053293  
Product Classification Hip Prosthesis, Porous Coated Femoral Stem - Product Code MBL
Product 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.
Code Information REF Number 108- 1017, 1019, 1217, 1219, 1221, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827. All Lot numbers.
Recalling Firm/
Manufacturer		 Ortho Development Corporation
12187 South Business Park Dr
Draper UT 84020
For Additional Information Contact
801-619-3450
Manufacturer Reason
for Recall		 Tests on PVC packaging material resulted in alert levels for cytotoxicity.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBL and Original Applicant = ORTHO DEVELOPMENT CORP.
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