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U.S. Department of Health and Human Services

Class 2 Device Recall LINK MP Monoblock Trial Stem Instruments, Sizes 14mm 25mm

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  Class 2 Device Recall LINK MP Monoblock Trial Stem Instruments, Sizes 14mm 25mm see related information
Date Initiated by Firm July 03, 2023
Date Posted August 04, 2023
Recall Status1 Open3, Classified
Recall Number Z-2346-2023
Recall Event ID 92758
510(K)Number K183141  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur.
Item Number: 136-115/00
Code Information UDI-DI: 04026575182091 Lot Numbers: B923004 B932049 C005089 C211009
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information Contact SAME
494053995150
Manufacturer Reason
for Recall		 Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
FDA Determined
Cause 2		 Device Design
Action LinkBio Corp initiated Urgent Medical Device Recall Letter to US Distributors via email on July 6, 2023. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. These trials are contained in the MP Monoblock instrument sets. The entire instrument set must be returned as part of this recall. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address, referencing QT 2023-238: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions
Quantity in Commerce 24 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LZO and Original Applicant = Waldemar Link GmbH & Co. KG
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