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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Event Detail

Event ID 65800
Product Type Devices
Status Ongoing
Recalling Firm Waldemar Link GmbH & Co. KG (Corp. Hq.)
City Hamburg
State
Country DE
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-16
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Distribution to the state of Tennessee only.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lots: B206025, B048090, B101172 Class II The trial stems were manufactured using the wrong design. 8 units Z-2080-2013
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 Lots: B225115, B048089, B102030 Class II The trial stems were manufactured using the wrong design. 9 units Z-2079-2013
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 Lots: B225118, B101171 Class II The trial stems were manufactured using the wrong design. 8 units Z-2078-2013
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 Lots: B225114, B051033, B103049 Class II The trial stems were manufactured using the wrong design. 9 units Z-2077-2013
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 Lots: B225116, B128075 Class II The trial stems were manufactured using the wrong design. 6 units Z-2076-2013
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 Lots: B225082, B126052 Class II The trial stems were manufactured using the wrong design. 6 units Z-2075-2013
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 Lots: B208037, B225126 Class II The trial stems were manufactured using the wrong design. 5 units Z-2074-2013
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 Lots: B209035, B225120 Class II The trial stems were manufactured using the wrong design. 5 units Z-2073-2013
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 Lots: B209034, B225123 Class II The trial stems were manufactured using the wrong design. 4 units Z-2072-2013
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 Lots: B209033, B225119 Class II The trial stems were manufactured using the wrong design. 5 units Z-2071-2013
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 Lots: B208089, B225125 Class II The trial stems were manufactured using the wrong design. 5 units Z-2070-2013
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 Lots: B226103, B051034 Class II The trial stems were manufactured using the wrong design. 9 units Z-2069-2013
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 Lots: B208036, B225081 Class II The trial stems were manufactured using the wrong design. 7 units Z-2068-2013
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 Lots: B048087, B225117 Class II The trial stems were manufactured using the wrong design. 6 units Z-2067-2013
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 Lots: B208035 Class II The trial stems were manufactured using the wrong design. 5 units Z-2066-2013
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 Lots: B208034 Class II The trial stems were manufactured using the wrong design. 5 units Z-2065-2013
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 Lots: B208033 Class II The trial stems were manufactured using the wrong design. 5 units Z-2064-2013
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 Lots: B208032 Class II The trial stems were manufactured using the wrong design. 5 units Z-2063-2013
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 Lots: B226105, B128103 Class II The trial stems were manufactured using the wrong design. 6 units Z-2062-2013
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 Lots: B208031 Class II The trial stems were manufactured using the wrong design. 5 units Z-2061-2013
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 Lots: B208030, B225121 Class II The trial stems were manufactured using the wrong design. 4 units Z-2060-2013
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