Medical device manufacturer, Stryker Trauma GmbH, has issued a medical device safety alert concerning its T2 Locking Screws, Compression Screws, End Caps, Gamma3 End Caps. The affected devices are identified as follow:
- Product Description [Catalog Number; Lot Number]:
- Locking Screw, Fully Threaded S2 Ø5x35 mm [17965035S; K0386FB]
- Compression Screw, Advanced T2 Tibia [18220001S; K020791]
- End Cap T2 Tibia +10 mm [18220010S; K020795, K020796]
- End Cap, Standard T2 Humerus Ø6 mm [18300003S; K020793, K020794]
- End Cap T2 Humerus Ø6mm, 5mm height [18300005S; K02803B]
- End Cap T2 Humerus Ø6mm, 15mm height [18300015S; K037E2D]
- Locking Screw, Partially Threaded T2 Tibia Ø5x55 mm [18915055S; K01CF9F]
- Locking Screw, Fully Threaded T2 Humerus Ø4x32 mm [18964032S; K0207C2]
- Locking Screw, Fully Threaded T2 Tibia Ø5x30 mm [18965030S; K0207B0, K02C1A8, K02C1A9, K0302E4]
- Locking Screw, Fully Threaded T2 Tibia Ø5x35 mm [18965035S; K02AE3F, K02C191, K02C1AA, K0302F9, K0302FA, K0302FD, K030307, K030313, K030315, K030EE3, K030EE4, K030EE5, K030EE8, K031B63, K032879, K0E902D, K0E9086, K0E90B7, K0E90BB, K0EAC03]
- Locking Screw, Fully Threaded T2 Tibia Ø5x37,5 mm [18965037S; K029C38, K029C39, K030EF6, K030EF7, K030EF9, K031B66]
- Locking Screw, Fully Threaded T2 Tibia Ø5x40 mm [18965040S; K0207B3, K031B6B, K031B6C, K033439]
- Locking Screw, Fully Threaded T2 Tibia Ø5x45 mm [18965045S; K02C1BB, K03033E, K030342, K03035D, K030F17, K030F1D, K031B6E, K031B70, K0328A5]
- Locking Screw, Fully Threaded T2 Tibia Ø5x50 mm [18965050S; K030F1E, K033442]
- End Cap, Std, Ti Gamma3 [30051100S; K03A7FF]
The manufacturer investigated a nonconformance with a supplier and found that the coating of the sealing lids for the sterile packaging was defective for a part of a certain supplier batch. It cannot be completely excluded that parts of it have been put on the market.
According to the manufacturer, integrity of the sterile barrier cannot be assured over 5 years shelf life. Therefore, a risk of infection due to the use of an improperly sealed device cannot be excluded. On the other hand, if these implants were used in a patient and no complications have occurred yet after these surgeries, it is not very likely these complications will still occur. Most infections occur and become apparent within the first 30-days after surgery. This is not a recall to explant the devices.
The manufacturer will recall all unused items, which are limited to specific lot numbers. All other lots are not affected and can be used.
Affected users are instructed to take the following actions:
- Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at their facility.
- Quarantine and discontinue use of the recalled devices.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 May 2020