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Various trauma and sports medicine instruments and implants recallZ-1817-2016 · 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-1817-2016
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
HRS
FDA submissions
K093880, K111663
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. Plate, fixation, bone.

Code information (models, lots, serial numbers)

Part #'s 24616 131212112 131212113 131212114 131212116 131212118 131212216 131212218 131212220 131212222 131212224 131212316 131212318 131212320 131212322 856135016 856135018 856135020 856135022 856135024 856135026 856135028 856135030 856135034 856135036 856135038 856135040 856135042   Lot #'s 606160 729130 664900 752650 752660 664910 664930 752680 664950 752690 752720 664990 665020 665040 665060 665070 665090 665100 665120 665130 758430 758500 758520 758540 758550 758570 758670 758680 758700 758710 758720 758730 758740

Other devices under the same FDA submission

3 devices cleared under K093880, K111663 — 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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