Trauma Internal Fixation Systems

• • Terminated Z-0811-2022 FDA Class II ·initiated 14 Feb 2022 ·on shared 510(k) K111663

  Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.

• 11 recalls, same reason

  • Terminated Z-1234-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1231-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1227-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1229-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1233-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1225-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1228-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1226-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1232-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1235-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663
  • Terminated Z-1230-2018 FDA Class II ·initiated 20 Dec 2017 ·on shared 510(k) K111663

  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.

• • Terminated Z-1306-2018 FDA Class II ·initiated 25 Oct 2017

  The drill guides were manufactured with the incorrect color anodization.

• • Terminated Z-1817-2016 FDA Class II ·initiated 1 Apr 2016

  Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

• • Terminated Z-0450-2016 FDA Class II ·initiated 20 Nov 2015

  These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the screw does not lock into the plate and backs out, a revision surgery may be necessary.

• • Terminated Z-2058-2015 FDA Class II ·initiated 4 Jun 2015

  Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.

• • Terminated Z-2046-2015 FDA Class II ·initiated 4 Jun 2015

  The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper purchase. This may require a revision surgery to replace or remove the screw and/or plate. The threads, not uniformly loaded, may shear off, causing metal slivers.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 20 Dec 2017 Recall initiated FDA recalls Z-1227-2018
2. 20 Dec 2017 Recall initiated FDA recalls Z-1229-2018
3. 20 Dec 2017 Recall initiated FDA recalls Z-1233-2018
4. 20 Dec 2017 Recall initiated FDA recalls Z-1225-2018
5. 20 Dec 2017 Recall initiated FDA recalls Z-1228-2018
6. 20 Dec 2017 Recall initiated FDA recalls Z-1226-2018
7. 20 Dec 2017 Recall initiated FDA recalls Z-1232-2018
8. 20 Dec 2017 Recall initiated FDA recalls Z-1235-2018
9. 20 Dec 2017 Recall initiated FDA recalls Z-1230-2018
10. 14 Feb 2022 Recall initiated FDA recalls Z-0811-2022

8 earlier events are in the sections above.

510(k) Number

K111663 ↗

FDA product code

HRS

Device class

Class II

Regulation

21 CFR Part 888.3030

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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