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SPII Model Lubinus recallZ-1296-2024 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Feb 6, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 [email protected] for any questions.

Recall details

Recall number
Z-1296-2024
Status
Open, Classified
Initiated by the company
Feb 6, 2024
Posted by the FDA
Mar 14, 2024
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
382 units
Product code
JDG
FDA submissions
K953653
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.

Product description

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

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);

Devices named in this recall

99 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

77 devices cleared under K953653 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94078).

Sources and updates

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