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

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.

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 [email protected]. 3. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be provided which should be used to return recalled product. 4. Upon receipt of the recalled product, Stryker will contact you to arrange for replacement or credit. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. If you have any questions or concerns, please contact Sylvia Page at (269) 501-8375 or email at [email protected]. Expanded Recall: A second notification Medical Device Recall Expansion Letter letter dated 1/5/21 issued via FedEx second day to the US consignees.