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Various trauma and sports medicine instruments and implants recallZ-1819-2016 · Biomet, Inc. · initiated Apr 1, 2016

Class II Terminated All recalls posted in May 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Equipment maintenance

What the company is doing

Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recall details

Recall number
Z-1819-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 1, 2016
Posted by the FDA
May 26, 2016
Recalling firm
Biomet, Inc.
Product code
HSB
FDA submissions
K050118, K063570, K091976, K871539
Distribution
Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

Product description

Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.

Code information (models, lots, serial numbers)

Part #'s 28234 28338 28811 28813 28821 29260 29822 805065080 14-400428 14-400436 14-405032 14-405040 14-440118 14-440121 14-441280 14-440066S  Lot #'s 590970 591080 591090 665210 692040 692250 692280 692290 695900 610470 665230 665240 692440 692450 692480 692620 692660 692670 692690 721680 721720 721730 729080 722730 621840 621860 678300 664740 664820 664870 664880 503760 503770 693840 476230

Other devices under the same FDA submission

23 devices cleared under K050118, K063570, K091976, K871539 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 74038).

Sources and updates

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