FDAClass IIDecember 4, 2013

2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive recall: Labeling Error

2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of…

Why was 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive recalled?

Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm 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?

Lot 3420620

Product
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of…
Recalling firm
Synthes USA HQ, Inc.
Quantity
98
Distribution
Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.
Recall date
December 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls