CLASS II Device recall · Reported 1 Jun 2016 · FDA Enforcement Report
Various trauma and sports medicine instruments and implants recalled
Biomet is recalling Various trauma and sports medicine instruments and implants, distributed nationwide in the US. The recall was initiated on 1 Apr 2016 and the FDA has classified it as Class II.
Check your package
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-1817-2016
- FDA event ID
- 74038
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2016
- FDA classified
- 26 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 1 Apr 2016 | Recall initiated by company | |
| 26 May 2016 | Classified by FDA | +55 days |
| 1 Jun 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
Where it was distributed
Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
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.
Other products in this recall event
13 other products · FDA event 74038This product is part of a recall event; the main page for the event is Various trauma and sports medicine instruments and implants recalled.
More recalls from Biomet
All 279| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
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