CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report
Locking Screw, Fully Threaded T2 Tibia ¿ mm recalled by Stryker
Stryker is recalling Stryker Locking Screw, Fully Threaded T2 Tibia ¿ mm, distributed nationwide in the US. The recall was initiated on 7 May 2020 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-2384-2020
- FDA event ID
- 85681
- Recalling firm
- Stryker, Selzach
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 May 2020
- FDA classified
- 16 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 7 May 2020 | Recall initiated by company | |
| 16 Jun 2020 | Classified by FDA | +40 days |
| 24 Jun 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Seal integrity of the blister pack may be compromised and sterility cannot be assured
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
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
Questions about this recall
Is Locking Screw, Fully Threaded T2 Tibia ¿ mm recalled?
Yes. Stryker recalled Locking Screw, Fully Threaded T2 Tibia ¿ mm on 7 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2384-2020.
Why was it recalled?
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Which lots are affected?
Lot Number: K0207B3, K031B6B, K031B6C, K033439
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
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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