FDAClass IIApril 4, 2018

ACE Trochanteric Nail System Ster L H Troc Nail recall

ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER…

Why was ACE Trochanteric Nail System Ster L H Troc Nail recalled?

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

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?

915209320 915209340 915209360 915209380 915209400 915209420 915209440 915209460 915211320 915211340 915211360 915211380 915211400 915211420 915211440 915211460 915213320 915213340 915213360 915213380 915213400 915213420 915213440 915213460 916209320 916209340 916209360 916209380 916209400 916209420 916209440 916209460 916211320 916211340 916211360 916211380 916211400 916211420 916211440 916211460 916213320 916213340 916213360 916213380 916213400 916213420 916213440 916213460 925200320 925209320 925209340 925209360 925209380 925209400 925209420 925209440 925209460 925211340 925211360 925211380 925211400 925211420 925211440 925211460 925213320 925213340 925213360 925213380 925213400 925213420 925213440 925213460 926209320 926209340 926209360 926209380 926209400 926209420 926209440 926209460 926211320 926211340 926211360 926211380 926211400 926211420 926211440 926213320 926213340 926213360 926213380 926213400 926213420 926213440 926213460 935209320 935209340 935209360 935209380 935209400 935209420 935209440 935209460 935211320 935211340 935211360 935211380 935211400 935211420 935211440 935211460 935213320 935213340 935213360 935213380 935213400 935213420 935213440 935213460 936213320 936213340 936213360 936213380 936213400 936213420 936213440 936213460 936309320 936309340 936309360 936309380 936309400 936309420 936309440 936309460 936311320 936311340 936311360 936311380 936311400 936311420 936311440 936311460

Product
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER…
Recalling firm
Zimmer Biomet, Inc.
Quantity
3454
Distribution
USA (nationwide)
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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