FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Corp. Hq.): 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
- Recall number
- Z-2070-2013
- Recalling firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Product
- 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
- Status
- Terminated
- Initiated
- 2013-07-16
- Posted
- 2013-08-26
- Terminated
- 2014-06-04
- Reason
- The trial stems were manufactured using the wrong design.
- Root cause
- Device Design
- Action
- The firm notified their consignees of their product recall by parcel post on 07/16/2013.
- Quantity
- 5 units
- Distribution
- US Distribution to the state of Tennessee only.
- Lot, serial or model codes
- Lots: B208089, B225125
- 510(k) numbers
- ["K955296"]
- PMA numbers
- not on file
- Product code
- HWT
- Firm FEI
- 3002808472
- Firm city
- Hamburg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28