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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Made Device GMRS EXTENSION Piece 40MM LEFT

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 Class 2 Device Recall Custom Made Device GMRS EXTENSION Piece 40MM LEFTsee related information
Date Initiated by FirmAugust 05, 2024
Date PostedAugust 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2732-2024
Recall Event ID 95114
510(K)NumberK023087 K222056 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductCustom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Code Information Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactLoriann Russo
201-831-5000
Manufacturer Reason
for Recall		A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
FDA Determined
Cause 2		Process control
ActionOn August 5, 2024 an URGENT MEDICAL DEVICE RECALL letter was sent to their consignee. Actions Needed: Our records indicate that you have received the affected product, and that product has already been returned to Stryker. We therefore request that you read this notice carefully and complete the following actions. 1. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form. Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. We regret any inconvenience this action may cause. For questions pertaining to the recall, please email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
Quantity in Commerce 1 unit (OUS only)
DistributionInternational distribution to the country of Australia.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JDI
510(K)s with Product Code = JDI
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