Z-2078-2013Class II

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length...

Name: Z-2078-2013 TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length...
Creator: Waldemar Link GmbH & Co. KG (Corp. Hq.)
Published: 2013-07-16
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG (Corp. Hq.) / initiated 2013-07-16 / Terminated / root cause: design

FDA source

Waldemar Link GmbH & Co. KG (Corp. Hq.) began a recall of 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... on 2013-07-16. FDA classified it as Class II and gives the reason as "The trial stems were manufactured using the wrong design". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2078-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-16
Posted: 2013-08-26
Terminated: 2014-06-04
Recalling firm: Waldemar Link GmbH & Co. KG (Corp. Hq.)
Product: 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
Product code: HWT Template
Reason for recall: The trial stems were manufactured using the wrong design.
Root cause tag: design
FDA root cause: Device Design
Action: The firm notified their consignees of their product recall by parcel post on 07/16/2013.
Quantity in commerce: 8 units
Distribution: US Distribution to the state of Tennessee only.
Product codes and lots: Lots: B225118, B101171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2078-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2060-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2061-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2062-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2063-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2064-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2065-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2066-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2067-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2068-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2069-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2070-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2071-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2072-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2073-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2074-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2075-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2076-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2077-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2078-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2079-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27
Z-2080-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27

Product code HWT

K955296Class IILink Mp Reconstruction HipLink America, Inc. / cleared 1996-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)