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U.S. Department of Health and Human Services

Class 2 Device Recall Trident PSL Acetabular Shell;

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 Class 2 Recall
Trident PSL Acetabular Shell;
see related information
Date Posted September 26, 2007
Recall Status1 Terminated on January 18, 2008
Recall Number Z-1261-2007
Recall Event ID 38815
Premarket Notification
510(K) Number
K983382 
Product Classification Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate - Product Code MEH
Product Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., 325 Corporate DriveMahway, NJ 07430
Code Information Catalog number/ lot code: 540-11-56F 36906101 540-11-58G 37048901 540-11-58G 37122001 542-11-46D 34977701 542-11-46D 35105901 542-11-46D 35382701 542-11-46D 35483101 542-11-46D 35525001 542-11-46D 35584201 542-11-46D 37497001 542-11-46D 37830601 542-11-46D 37884701 542-11-46D 38034101 542-11-46D 38124501 542-11-48D 35028401 542-11-48D 35332701 542-11-48D 35406002 542-11-48D 35406003 542-11-48D 35687701 542-11-48D 35726401 542-11-48D 35834801 542-11-48D 37790101 542-11-48D 37891501 542-11-48D 38025001 542-11-48D 38025002 542-11-48D 38160501 542-11-50E 35032701 542-11-50E 35207301 542-11-50E 35385903 542-11-50E 35428901 542-11-50E 35428903 542-11-50E 35481501 542-11-50E 35481502 542-11-50E 35481502 542-11-50E 35515802 542-11-50E 35827902 542-11-50E 36966303 542-11-50E 37344301 542-11-50E 37515302 542-11-50E 37695201 542-11-50E 37888201 542-11-50E 37920201 542-11-50E 38245801 542-11-50E 38274303 542-11-52E 32886803 542-11-52E 35018402 542-11-52E 35018403 542-11-52E 35018404 542-11-52E 35085001 542-11-52E 35199201 542-11-52E 35199202 542-11-52E 35199204 542-11-52E 35325401 542-11-52E 35325403 542-11-52E 35373402 542-11-52E 35373403 542-11-52E 35419904 542-11-52E 35726002 542-11-52E 35866302 542-11-52E 35866304 542-11-52E 37057001 542-11-52E 37096702 542-11-52E 37368002 542-11-52E 37886202 542-11-52E 37886204 542-11-52E 37886206 542-11-52E 37925602 542-11-52E 37995901 542-11-52E 37995902 542-11-54F 35091602 542-11-54F 35186502 542-11-54F 35732703 542-11-54F 35868801 542-11-54F 35965101 542-11-54F 37443401 542-11-54F 37443403 542-11-54F 37789201 542-11-54F 37916502 542-11-54F 38095601 542-11-54F 38223203 542-11-56F 35081001 542-11-56F 35225301 542-11-56F 35225302 542-11-56F 35225303 542-11-56F 35290801 542-11-56F 35335101 542-11-56F 35524501 542-11-56F 35535102 542-11-56F 35831001 542-11-56F 36330001 542-11-56F 36542101 542-11-56F 36542102 542-11-56F 36768001 542-11-56F 36907201 542-11-56F 37050902 542-11-56F 37461501 542-11-56F 37743301 542-11-56F 38099001 542-11-58G 35638002 542-11-58G 35959701 542-11-58G 35959702 542-11-58G 36052801 542-11-58G 36137301 542-11-58G 36195501 542-11-58G 36195502 542-11-58G 36332802 542-11-58G 36372301 542-11-58G 36412601 542-11-58G 36430601 542-11-58G 36489601 542-11-58G 36489602 542-11-58G 36553001 542-11-58G 36583801 542-11-58G 36633201 542-11-58G 36758901 542-11-58G 36758902 542-11-58G 36898201 542-11-58G 37049101 542-11-58G 37049102 542-11-58G 37049103 542-11-58G 37122401 542-11-58G 37122402 542-11-58G 37122403 542-11-58G 37173201 542-11-58G 37242901 542-11-58G 37242902 542-11-58G 37279901 542-11-58G 37332301 542-11-58G 37500801 542-11-58G 37500801 542-11-58G 37500803 542-11-58G 37826804 542-11-60G 34806101 542-11-60G 34907101 542-11-60G 35666901 542-11-60G 35946101 542-11-60G 36002201 542-11-60G 36406701 542-11-60G 36435401 542-11-60G 36765101 542-11-60G 37119701 542-11-60G 37119702 542-11-60G 37273901 542-11-60G 37402101 542-11-62G 37358901 542-11-62H 34930801 542-11-62H 35272101 542-11-62H 35508901 542-11-62H 36270401 542-11-62H 36842101 542-11-64H 36406301 542-11-64H 37082601 542-11-64H 37358801 542-11-64H 37859901
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Larry Ross
201-831-5972
Manufacturer Reason
for Recall
Dimensional anomaly
FDA Determined
Cause 2
TRAINING: Employee Error
Action Recall Notification letters were sent on March 13, 2006 to all hospitals, branches/agencies via Federal Express.
Quantity in Commerce 1,220 units
Distribution Worldwide -USA, Romania, Chile and Brazil.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = OSTEONICS CORP.
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