CLASS II Device recall · Reported 17 Jan 2018 · FDA Enforcement Report

Mac Pin Non-Cannulated Screw recalled by Amendia

Amendia is recalling Mac Pin Non-Cannulated Screw, 6.5, distributed in Georgia. The recall was initiated on 7 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #85-6560-1, Lot #132117

Quantity recalled41 screws

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0325-2018
FDA event ID: 77991
Recalling firm: Amendia, Marietta, GA
Classification: Class II
Status: Terminated
Recall initiated: 7 Jul 2017
FDA classified: 10 Jan 2018
Reported: 17 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

7 Jul 2017	Recall initiated by company
10 Jan 2018	Classified by FDA	+187 days
17 Jan 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Where it was distributed

Distribution to Georgia, USA.

Georgia

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model #85-6560-1, Lot #132117

Where was it sold?

Distribution to Georgia, USA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Amendia

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18 Jan 2017Device	CLASS II	Ceres-C Standalone Cervical Interbody The product recalled by Amendia	Amendia	Other	GA
28 Dec 2016Device	CLASS II	Black Widow Plate recalled by Amendia	Amendia	Other	Nationwide

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