CLASS II Device recall · Reported 16 Jan 2019 · FDA Enforcement Report
Biomet DVR Crosslock Screws-, Sterile recalled by Zimmer Biomet
Zimmer Biomet is recalling Biomet DVR Crosslock Screws-, Sterile. The recall was initiated on 20 Nov 2018 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-0709-2019
- FDA event ID
- 81704
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2018
- FDA classified
- 10 Jan 2019
- Reported
- 16 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 20 Nov 2018 | Recall initiated by company | |
| 10 Jan 2019 | Classified by FDA | +51 days |
| 16 Jan 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
One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone
Where it was distributed
Country of Japan
Questions about this recall
Is Biomet DVR Crosslock Screws-, Sterile recalled?
Yes. Zimmer Biomet recalled Biomet DVR Crosslock Screws-, Sterile on 20 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0709-2019.
Why was it recalled?
One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
Which lots are affected?
LOT 029970 UDI (01)00880304535572(17)280501(10)029970
Where was it sold?
Country of Japan
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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