Recall Z-0431-2021 ยท HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Stryker Instruments Div. of Stryker Corporation
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
| Date | Nov 6, 2020 (initiated Oct 16, 2020) |
| Status | Terminated |
| Reason | Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use. |
| Root cause | Nonconforming Material/Component |
| Action | Zimmer issued Medical Device Recall letters via 2-day FedEx shipping on 16OCT2020 stating reason for recall, health risk and action to take: Immediately check your internal inventory to locate the affected products. Quarantine and discontinue use of any affected Disposable Cranial Perforator Bits. 2. Return the enclosed business reply form (BRF) even if you dont have any affected product on hand, via fax (866) 521-2762 or email to instruments.recalls@stryker.com. 3. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be provided which shoul |
| Quantity | 18,492 devices. Expanded Recall total: 18,594 devices |
| Distribution | Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT Stryker Ireland Ltd., Instruments Division, Dec 29, 2008 |