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U.S. Department of Health and Human Services

Class 2 Device Recall LINK SPII Model Lubinus, Hip Prosthesis Stem

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  Class 2 Device Recall LINK SPII Model Lubinus, Hip Prosthesis Stem see related information
Date Initiated by Firm February 06, 2024
Date Posted March 14, 2024
Recall Status1 Open3, Classified
Recall Number Z-1299-2024
Recall Event ID 94078
510(K)Number K953653  
Product Classification Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
Product SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Code Information Product Code (UDI/DI): 127-940/26 (04026575335572) , 127-940/35 (04026575335589) , 127-941/26 (04026575335596) , 127-941/35 (04026575335602) , 127-942/26 (04026575335619) , 127-942/35 (04026575335626) , 127-943/26 (04026575335633) , 127-943/35 (04026575335640) , 127-944/26 (04026575335657) , 127-944/35 (04026575335664) , 127-945/26 (04026575335671) , 127-945/35 (04026575335688) , 127-946/26 (04026575335695) , 127-946/35 (04026575335701) , 127-947/26 (04026575335718) , 127-947/35 (04026575335725), 127-948/26 (04026575335732) , 127-948/35 (04026575335749) , 127-949/26 (04026575335756) , 127-949/35 (04026575335763) , 127-950/26 (04026575335770) , 127-950/35 (04026575335787) , 127-951/26 (04026575335794) , 127-951/35 (04026575335800) , 127-952/26 (04026575335817) , 127-952/35 (04026575335824) , 127-953/26 (04026575335831) , 127-953/35 (04026575335848) , 127-954/26 (04026575335855) , 127-954/35 (04026575335862) , 127-955/26 (04026575335879) , 127-955/35 (04026575335886), 127-956/26 (04026575335893) , 127-956/35 (04026575335909) , 127-957/26 (04026575335916) , 127-957/35 (04026575335923) , 127-958/26 (04026575335930) , 127-958/35 (04026575335947) , 127-959/26 (04026575335954) , 127-959/35 (04026575335961) , 127-960/26 (04026575335978) , 127-960/35 (04026575335985) , 127-961/26 (04026575335992) , 127-961/35 (04026575336005) , 127-962/26 (04026575336012) , 127-962/35 (04026575336029) , 127-963/26 (04026575336036) , 127-963/35 (04026575336043);
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information Contact Jennifer Lubrecht
862-477-0370
Manufacturer Reason
for Recall		 Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Correction (UMDC) Letters were sent via email to consignees on February 16, 2024. Actions to be taken by the customer/user: Please take note of the clarification of the carton label noted in section 2. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to correctly interpret the Size and Type columns on the label. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
Quantity in Commerce 0 units
Distribution US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.
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 = JDG and Original Applicant = TURNKEY INTERGRATION USA, INC.
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