Date Initiated by Firm | March 13, 2006 |
Date Posted | September 26, 2007 |
Recall Status1 |
Terminated 3 on January 18, 2008 |
Recall Number | Z-1261-2007 |
Recall Event ID |
38815 |
510(K)Number | K983382 |
Product Classification |
Acetabular Shell - 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 NJ 07430-2002
|
For Additional Information Contact | Larry Ross 201-831-5972 |
Manufacturer Reason for Recall | Dimensional anomaly |
FDA Determined Cause 2 | Other |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = MEH
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