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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker LFIT Anatomic V40 Femoral Head

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 Class 2 Device Recall Stryker LFIT Anatomic V40 Femoral Headsee related information
Date Initiated by FirmAugust 29, 2016
Create DateNovember 09, 2016
Recall Status1 Terminated 3 on May 02, 2017
Recall NumberZ-0378-2017
Recall Event ID 75246
510(K)NumberK022077 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductLFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Code Information Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #6260-9-240 - Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-244 - Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-340 - Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-440 - Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and Catalog #6260-9-444 - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactMr. Michael Van Ryn
201-831-5000
Manufacturer Reason
for Recall		Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
FDA Determined
Cause 2		Under Investigation by firm
ActionStryker notified their Branches/Agencies of this recall by e-mail on August 29, 2016 and they were asked to quarantine the affected devices. A Recall Notification Letter and Product Accountability Form was also sent on August 29, 2016 via UPS (with return receipt) to their Branches/Agencies/Hospital Risk Management and Surgeons. On October 11, 2016, Stryker sent an updated recall notification via UPS with return receipt to their affected customers because additional customers and lot numbers were identified.
Quantity in Commerce42,519 units (total Catalog numbers)
DistributionUS Nationwide and Internationally
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 = JDI
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