FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
- Recall number
- Z-1299-2024
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
- Status
- Open, Classified
- Initiated
- 2024-02-06
- Posted
- 2024-03-14
- Terminated
- not on file
- 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 Type columns to avoid misinterpretation during surgery.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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);
- 510(k) numbers
- ["K953653"]
- PMA numbers
- not on file
- Product code
- JDG
- Firm FEI
- 3003386935
- Firm city
- Norderstedt
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28