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U.S. Department of Health and Human Services

Class 2 Device Recall Pivot BiPolar Head

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 Class 2 Device Recall Pivot BiPolar Headsee related information
Date Initiated by FirmApril 29, 2009
Date PostedOctober 28, 2009
Recall Status1 Terminated 3 on May 25, 2010
Recall NumberZ-0086-2010
Recall Event ID 52048
510(K)NumberK050966 
Product Classification hip prosthesis - Product Code KWY
ProductOrtho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
Code Information Part 133-2846, Lots 3370, 3534, 3620, 3731 Part 133-2847, Lots 3492, 3535 Part 133-2848, Lot 3509 Part 133-2851, Lot 3433 Part 133-2852, Lot 3661
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		A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.
FDA Determined
Cause 2		Device Design
ActionOrtho sent a Field notification Memo dated 4/2/2009 to agents and distributors, giving them pre-implant examination guidelines. Decision to recall non-implanted units was made on 4/29/2009 and this was communicated by telephone to distributors.
Quantity in Commerce23
DistributionAZ, CA, FL, MA, MI. No military, government or foreign distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KWY
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