FDAClass IINovember 4, 2015

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess recall: Labeling Error

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures…

Why was 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess recalled?

Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

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?

Part Number 202.212 Lot Number 3420620

Product
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures…
Recalling firm
Synthes (USA) Products LLC
Quantity
98
Distribution
US Distribution to the state of : TN
Recall date
November 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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