CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report
Various temporary devices used during the implantation recalled
Zimmer Biomet is recalling Various temporary devices used during the implantation of the device system: bone, distributed nationwide in the US. The recall was initiated on 10 Oct 2019 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-0329-2020
- FDA event ID
- 83962
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2019
- FDA classified
- 7 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 10 Oct 2019 | Recall initiated by company | |
| 7 Nov 2019 | Classified by FDA | +28 days |
| 13 Nov 2019 | 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
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 47225806700
Where it was distributed
Distributed nationwide.
Questions about this recall
Is Various temporary devices used during the implantation of the device system: bone recalled?
Yes. Zimmer Biomet recalled Various temporary devices used during the implantation of the device system: bone on 10 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-0329-2020.
Why was it recalled?
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Which lots are affected?
All products manufactured prior to January 2014.
Where was it sold?
Distributed nationwide.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |