Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 4, 2018
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
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Biomet, Inc. recalled AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL … - a moderate-severity action.
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL … was recalled by Zimmer Biomet, Inc. in April 4, 2018. Reason: The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance crit…. Check the official notice for the remedy. Verify recall #Z-1197-2018 with the FDA Devices before acting.
The recall
Zimmer Biomet, Inc. issued this moderate-severity FDA Devices recall-The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance crit….
- Moderate
- severity level
- Class II
- classification
- April 4, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1197-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1197-2018) was formally reported on April 4, 2018, with the manufacturer initiating the action on February 6, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as Not known.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide and US of Indiana and country of the Republic of Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Not known
Related Recalls
6
3 from same agency
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1197-2018 |
| Date reported | April 4, 2018 |
| Date initiated | February 6, 2018 |
| Recalling firm | Zimmer Biomet, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | Not known |
| Distribution | Worldwide and US of Indiana and country of the Republic of Korea. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1197-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer Biomet, Inc.. Units affected: Not known.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1197-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide and US of Indiana and country of the Republic of Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1197-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 4, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.