| Class 2 Device Recall LINK MP Monoblock Trial Stem Instruments, Sizes 14mm 25mm | |
Date Initiated by Firm | July 03, 2023 |
Date Posted | August 04, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2348-2023 |
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
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Product | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur
Item Number: 136-117/00 |
Code Information |
UDI-DI: 04026575182114
Lot Numbers:
B922124
B932051
C005064
C211011
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Recalling Firm/ Manufacturer |
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
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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.
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = LZO
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