LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
- Recall Initiated
- July 3, 2023
- Posted
- August 4, 2023
- Recall Number
- Z-2347-2023
- Quantity
- 24 units
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
Distribution
US Nationwide distribution.
Lot / Code Info
UDI-DI: 04026575182107 Lot Numbers: B923003 B932050 C005075 C211010
Root Cause
Device Design
Action Taken
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