CLASS II ONGOING Device recall · Reported 20 Mar 2024 · FDA Enforcement Report

Spii Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented recalled

Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Spii Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented, distributed nationwide in the US. The recall was initiated on 6 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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 recalled382 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1296-2024
FDA event ID: 94078
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 6 Feb 2024
FDA classified: 14 Mar 2024
Reported: 20 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

6 Feb 2024	Recall initiated by company
14 Mar 2024	Classified by FDA	+37 days
20 Mar 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

Where it was distributed

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.

Nationwide Alabama Arizona California Florida Georgia Idaho Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan New Jersey Nevada Pennsylvania Tennessee Texas Virginia Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

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);

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 94078

This product is part of a recall event; the main page for the event is Spii Model Lubinus, Long Stem Prosthesis XL Neck, cemented recalled.

Reported	Class	Recall	Company	Reason	Where
20 Mar 2024	CLASS II	Spii Model Lubinus, Long Stem Prosthesis XL Neck, cemented recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	Nationwide
20 Mar 2024	CLASS II	Spii Model Lubinus, Long Stem Prosthesis Standard Neck, cemented recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	Nationwide
20 Mar 2024	CLASS II	Spii Model Lubinus, Hip Prosthesis Stem XL Neck, cemented recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	Nationwide

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
1 Apr 2026Device	CLASS II	Embrace Drill Tower, Standard/Lateral recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	15 states
1 Apr 2026Device	CLASS II	Embrace Drill Tower, Wedged recalled by Waldemar Link GmbH & Co. KG	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	15 states
18 Mar 2026Device	CLASS II	Endo-Model Replacement Plateau; Item Number: 15-0027/16 recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	Nationwide
18 Mar 2026Device	CLASS II	Endo-Model Replacement Plateau; Item Number: 15-0027/12 recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide