LINK STEM with Microporous Surface MP Reconstruction recall
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage…
Why was LINK STEM with Microporous Surface MP Reconstruction recalled?
The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 1435077 1515029 1718103 1435077 150401/0217 1734168 1726056 1718103 1734168 1515029
- Product
- LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage…
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 11
- Distribution
- US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN.
- Recall date
- January 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)