Recall record at a glance
| Official record | Z-1197-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Biomet, Inc. |
| Report date | Apr 4, 2018 |
| Recall initiation date | Feb 6, 2018 |
| Quantity | Not known |
| Location | Warsaw, IN, United States |
Official product description
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 810508345 NAIL TIB DYN 08 X 34.5 810508360 NAIL TIB DYN 08 X 36.0 810508375 NAIL TIB DYN 08 X 37.5 810508390 NAIL TIB DYN 08 X 39.0 810508405 NAIL TIB DYN 08 X 40.5 810508420 NAIL TIB DYN 08 X 42.0 810509255 NAIL TIB DYN 09 X 25.5 810509270 NAIL TIB DYN 09 X 27.0 810509285 NAIL TIB DYN 09 X 28.5 810509300 NAIL TIB DYN 09 X 30.0 810509315 NAIL TIB DYN 09 X 31.5 810509330 NAIL TIB DYN 09 X 33.0 810509345 NAIL TIB DYN 09 X 34.5 810509360 NAIL TIB DYN 09 X 36.0 810509375 NAIL TIB DYN 09 X 37.5 810509390 NAIL TIB DYN 09 X 39.0 810509405 NAIL TIB DYN 09 X 40.5 810509420 NAIL TIB DYN 09 X 42.0 810510255 NAIL TIB DYN 10 X 25.5 810510270 NAIL TIB DYN 10 X 27.0 810510285 NAIL TIB DYN 10 X 28.5 810510300 NAIL TIB DYN 10 X 30.0 810510315 NAIL TIB DYN 10 X 31.5 810510330 NAIL TIB DYN 10 X 33.0 810510345 NAIL TIB DYN 10 X 34.5 810510360 NAIL TIB DYN 10 X 36.0 810510375 NAIL TIB DYN 10 X 37.5 810510390 NAIL TIB DYN 10 X 39.0 810510405 NAIL TIB DYN 10 X 40.5 810510420 NAIL TIB DYN 10 X 42.0 810511255 NAIL TIB DYN 11 X 25.5 810511270 NAIL TIB DYN 11 X 27.0 810511285 NAIL TIB DYN 11 X 28.5 810511300 NAIL TIB DYN 11 X 30.0 810511315 NAIL TIB DYN 11 X 31.5 810511330 NAIL TIB DYN 11 X 33.0 810511345 NAIL TIB DYN 11 X 34.5 810511360 NAIL TIB DYN 11 X 36.0 810511375 NAIL TIB DYN 11 X 37.5 810511390 NAIL TIB DYN 11 X 39.0 810511405 NAIL TIB DYN 11 X 40.5 810511420 NAIL TIB DYN 11 X 42.0 810512270 NAIL TIB DYN 12 X 27.0 810512285 NAIL TIB DYN 12 X 28.5 810512300 NAIL TIB DYN 12 X 30.0 810512315 NAIL TIB DYN 12 X 31.5 810512330 NAIL TIB DYN 12 X 33.0 810512345 NAIL TIB DYN 12 X 34.5 810512360 NAIL TIB DYN 12 X 36.0 810512375 NAIL TIB DYN 12 X 37.5 810512390 NAIL TIB DYN 12 X 39.0 810512405 NAIL TIB DYN 12 X 40.5 810512420 NAIL TIB DYN 12 X 42.0 810513255 NAIL TIB DYN 13 X 25.5 810513285 NAIL TIB DYN 13MM X 28.5CM 810513300 NAIL TIB DYN 13MMX30.0 CM 810513315 NAIL TIB DYN 13MM X 31.5 CM 810513330 NAIL TIB DYN 13 X 33.0 810513345 NAIL TIB DYN 13MM X 34.5 CM 810513360 NAIL TIB DYN 13 X 36.0 MM 810513375 NAIL TIB DYN 13MM X 37.5 CM 810513390 NAIL TIB DYN 13MMX39.0CM 810513405 NAIL TIB DYN 13MM X 40.5 CM 810513420 NAIL TIB DYN 13MM X 42 CM Product Usage: A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device.
Why the product was recalled
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
Distribution information
Worldwide and US of Indiana and country of the Republic of Korea.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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