Amendia Mac Pin Screw Recall: Incorrect Length Labeling
Amendia recalls Mac Pin Non-Cannulated Screws (6.5 x 60mm) due to incorrect labeling of pin length. This may cause improper use in medical applications.
Lower-risk recall
Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
Contact the company
What happened, in plain English
Amendia is recalling Mac Pin Non-Cannulated Screws that have incorrect labeling about their length. This could lead to improper use in medical procedures if the screws are not the correct size. Read more at govinfonow.com/recall/73453-amendia-mac-pin-screw-recall-incorrect-length-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/73453-amendia-mac-pin-screw-recall-incorrect-length-labeling · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0325-2018
Cite this page
“Amendia Mac Pin Screw Recall: Incorrect Length Labeling.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73453-amendia-mac-pin-screw-recall-incorrect-length-labeling. Based on FDA recall #Z-0325-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0325-2018%22&limit=1).
Why it’s dangerous
The screws are labeled as 460 mm but are actually 60 mm long. This discrepancy could lead to improper surgical placement if the screws are used in medical procedures without the correct size.
Who’s affected
Medical professionals using these screws for surgical procedures may be affected. Patients receiving these screws could be at risk if the incorrect length causes complications.
How to tell if you have this one
Check for the model number 85-6560-1 and lot number 132117 on the screw packaging. These screws were sold by Amendia, Inc.
- Brand
Amendia- Category
Medical device
What to do — step by step
Check Product Label
Look for the model number 85-6560-1 and lot number 132117 on the screw packaging.
Where it went and when
Where it was distributed
Distributed in Georgia.
FDA distribution: “Distribution to Georgia, USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0325-2018 (July 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0325-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.