Recall Z-2076-2013
Waldemar Link GmbH & Co. KG (Corp. Hq.) · initiated July 16, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lots: B225116, B128075
Reason for recall
The trial stems were manufactured using the wrong design.
FDA-determined cause: Device Design
Action taken
The firm notified their consignees of their product recall by parcel post on 07/16/2013.
Details
- Recall number
- Z-2076-2013
- Initiated
- July 16, 2013
- Posted by FDA
- August 26, 2013
- Terminated
- June 4, 2014
- Product code
- HWT – Template
- Quantity
- 6 units
- Distribution
- US Distribution to the state of Tennessee only.
- Recalling firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.), Hamburg
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2060-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2061-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2062-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2063-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2064-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2065-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2066-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2067-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2068-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2069-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2070-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2071-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2072-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2073-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2074-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2075-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2077-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2078-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2079-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |
| Z-2080-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem…The trial stems were manufactured using the wrong design. | 07/16/2013Terminated |