SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Summary
The FDA issued a Class II for SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented by Waldemar Link GmbH & Co. KG (Mfg Site). Reason: Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Ty.
Details
Source
Device Recall
External ID
Z-1296-2024
Action Date
2024-03-20
Status
Ongoing
Category
device
Product Description
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Lot/Code Info: Product Code (UDI/DI): 127-610/17 (04026575387168) , 127-610/26 (04026575387304) , 127-610/35 (04026575387441), 127-612/17 (04026575387175) , 127-612/26 (04026575387311) , 127-612/35 (04026575387458) , 127-614/17 (04026575387182) , 127-614/26 (04026575387328) , 127-614/35 (04026575387465) , 127-616/17 (04026575387199) , 127-616/26 (04026575387335), 127-616/35 (04026575387472) , 127-618/17 (04026575387205) , 127-618/26 (04026575387342) , 127-618/35 (04026575387489) , 127-620/17 (04026575387212) , 127-620/26 (04026575387359) , 127-620/35 (04026575387496) , 127-622/17 (04026575387229) , 127-622/26 (04026575387366) , 127-622/35 (04026575387502) , 127-624/17 (04026575387236) , 127-624/26 (04026575387373) , 127-624/35 (04026575387519) , 127-626/17 (04026575387243) , 127-626/26 (04026575387380) , 127-626/35 (04026575387526) , 127-628/17 (04026575387250) , 127-628/26 (04026575387397) , 127-628/35 (04026575387533) , 127-630/17 (04026575387267) , 127-630/26 (04026575387403) , 127-630/35 (04026575387540) , 127-632/17 (04026575387274) , 127-632/26 (04026575387410) , 127-632/35 (04026575387557) , 127-634/17 (04026575387281) , 127-634/26 (04026575387427) , 127-634/35 (04026575387564) , 127-636/17 (04026575387298) , 127-636/26 (04026575387434) , 127-636/35 (04026575387571), 127-710/17 (04026575232154) , 127-710/26 (04026575232161) , 127-710/35 (04026575232178) , 127-711/17 (04026575232291) , 127-711/26 (04026575232307) , 127-711/35 (04026575232314) , 127-712/17 (04026575232147) , 127-712/26 (04026575024032) , 127-712/35 (04026575024049) , 127-713/17 (04026575232246) , 127-713/26 (04026575024056) , 127-713/35 (04026575024063) , 127-714/17 (04026575232192) , 127-714/26 (04026575024070) , 127-714/35 (04026575024087) , 127-715/17 (04026575230150) , 127-715/26 (04026575024094) , 127-715/35 (04026575024100) , 127-716/17 (04026575232208) , 127-716/26 (04026575024117) , 127-716/35 (04026575024124) , 127-717/17 (04026575232253) , 127-717/26 (04026575024131) , 127-717/35 (04026575024148) , 127-718/17 (04026575232215) , 127-718/26 (04026575024155) , 127-718/35 (04026575024162) , 127-719/17 (04026575232260) , 127-719/26 (04026575024179) , 127-719/35 (04026575024186) , 127-720/17 (04026575229628) , 127-720/26 (04026575225422) , 127-720/35 (04026575225439) , 127-721/17 (04026575229697) , 127-721/26 (04026575225507) , 127-721/35 (04026575225514) , 127-722/17 (04026575229635) , 127-722/26 (04026575024193) , 127-722/35 (04026575024209) , 127-723/17 (04026575229703) , 127-723/26 (04026575024216) , 127-723/35 (04026575024223), 127-724/17 (04026575229642) , 127-724/26 (04026575024230) , 127-724/35 (04026575024247) , 127-725/17 (04026575229710) , 127-725/26 (04026575024254) , 127-725/35 (04026575024261) , 127-726/17 (04026575229659) , 127-726/26 (04026575024278) , 127-726/35 (04026575024285) , 127-727/17 (04026575229727) , 127-727/26 (04026575024292) , 127-727/35 (04026575024308) , 127-728/17 (04026575229666) , 127-728/26 (04026575024315), 127-728/35 (04026575024322) , 127-729/17 (04026575229734) , 127-729/26 (04026575024339) , 127-729/35 (04026575024346) , 127-730/17 (04026575232239) , 127-730/26 (04026575024353) , 127-730/35 (04026575024360) , 127-731/17 (04026575232284) , 127-731/26 (04026575024377) , 127-731/35 (04026575024384) , 127-732/17 (04026575229680) , 127-732/26 (04026575024391) , 127-732/35 (04026575024407) , 127-733/17 (04026575229758) , 127-733/26 (04026575024414) , 127-733/35 (04026575024421) , 127-736/17 (04026575232222) , 127-736/26 (04026575225408) , 127-736/35 (04026575225415) , 127-737/17 (04026575232277) , 127-737/26 (04026575225460) , 127-737/35 (04026575225477) , 127-738/17 (04026575229673) , 127-738/26 (04026575225446) , 127-738/35 (04026575225453) , 127-739/17 (04026575229741) , 127-739/26 (04026575225484) , 127-739/35 (04026575225491);
Quantity Affected: 382 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-06
Company
Norderstedt, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Waldemar Link GmbH & Co. KG (Mfg Site) has 61 FDA actions in our database, including 61 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Waldemar Link GmbH & Co. KG (Mfg Site)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Waldemar Link GmbH & Co. KG (Mfg Site) have FDA actions?
Waldemar Link GmbH & Co. KG (Mfg Site) has 61 FDA actions in our database, including 61 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1296-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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