Device recall: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm…
Class II FDA enforcement event 65800. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The trial stems were manufactured using the wrong design.
Class II, in the words of FDA
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
Waldemar Link GmbH & Co. KG (Corp. Hq.) started this device recall on 16 Jul 2013. The firm address in the FDA record is in Hamburg. FDA put the recall in Class II. FDA event 65800 has 21 product records. The first FDA enforcement report date is 4 Sep 2013. The record gives the status Terminated, with the termination date 4 Jun 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Distribution to the state of Tennessee only.
Recalling firm
Waldemar Link GmbH & Co. KG (Corp. Hq.), Hamburg, Germany.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
21 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2060-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 4 units | Class II | Terminated | 4 Sep 2013 |
| Z-2061-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 5 units | Class II | Terminated | 4 Sep 2013 |
| Z-2062-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 6 units | Class II | Terminated | 4 Sep 2013 |
| Z-2063-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 5 units | Class II | Terminated | 4 Sep 2013 |
| Z-2064-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 5 units | Class II | Terminated | 4 Sep 2013 |
| Z-2065-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 5 units | Class II | Terminated | 4 Sep 2013 |
| Z-2066-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 5 units | Class II | Terminated | 4 Sep 2013 |
| Z-2067-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 6 units | Class II | Terminated | 4 Sep 2013 |
| Z-2068-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 7 units | Class II | Terminated | 4 Sep 2013 |
| Z-2069-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 9 units | Class II | Terminated | 4 Sep 2013 |
| Z-2070-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 5 units | Class II | Terminated | 4 Sep 2013 |
| Z-2071-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 5 units | Class II | Terminated | 4 Sep 2013 |
| Z-2072-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 4 units | Class II | Terminated | 4 Sep 2013 |
| Z-2073-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 5 units | Class II | Terminated | 4 Sep 2013 |
| Z-2074-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 5 units | Class II | Terminated | 4 Sep 2013 |
| Z-2075-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 6 units | Class II | Terminated | 4 Sep 2013 |
| Z-2076-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 6 units | Class II | Terminated | 4 Sep 2013 |
| Z-2077-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 9 units | Class II | Terminated | 4 Sep 2013 |
| Z-2078-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 8 units | Class II | Terminated | 4 Sep 2013 |
| Z-2079-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 9 units | Class II | Terminated | 4 Sep 2013 |
| Z-2080-2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | 8 units | Class II | Terminated | 4 Sep 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 21Median of the firm: 21
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Sep 2024 | LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01 Event 95344 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2060-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 65800. https://recallregister.com/fda/ii/65800/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Distribution to the state of Tennessee only.
- What quantity of product is in FDA event 65800?
- The event has 21 product records. The first record gives this quantity:
4 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.