Food, drugs, devices › Waldemar Link GmbH & Co. KG (Mfg Site)
Device recall: LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Nu
Waldemar Link GmbH & Co. KG (Mfg Site) (Norderstedt) initiated this device recall on 7 Dec 2018; FDA lists 1 product record under event 81778, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 17 Dec 2019. Initiation: voluntary: firm initiated. Waldemar Link GmbH & Co. KG (Mfg Site) has 22 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, Germany.
Reason for recall
"The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod."
Distribution
"US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0733-2019 | LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or… | 11 | Class II | Terminated | 23 Jan 2019 |
Context
Other enforcement events for Waldemar Link GmbH & Co. KG (Mfg Site)
All 22 events for Waldemar Link GmbH & Co. KG (Mfg Site)
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Dec 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.