Recall Z-0431-2021
Stryker Instruments Div. of Stryker Corporation · initiated October 16, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: GTIN: 04546540716224 Lot Numbers: 20029027 20030077 20030087 20031017 20031027 20034017 20035017 20035027 20035037 20036017 20036027 20038017 20038027 20040027 20041017 20042017 20044017 20044027 20047017 20048017 20048027 20048037 20051017 20052017 20052047 20055017 20055027 20055037 20055047 20056017 20057017 20057037 20058017 20058027 20059017 20059027 20059037 20059047 20062017 20062027 20062037 20062047 20063017 20063027 20064017 20066017 20066027 20066037 20066047 20069017 20069027 20071017 20071027 20072017 20079017 20079027 20080017 20083017 20083027 20084017 20084027 20084037 20084047 20084057 20094017 20094027 20094037 20094047 20099017 20099027 20099037 20101017 20101027 20101037 20101047 20101057 20101067 20101077 20106027 20106047 20106087 20106107 20106117 20106127 20106137 20107017 20107027 20107037 20107047 20107057 20108017 20108027 20108037 20108047 20108057 20108067 20111017 20111027 20111037 20112017 20112027 20112037 20112047 20113017 20113027 20113037 20118017 20118037 20120017 20120027 20120037 20121017 20121027 20122017 20122027 20122037 20122047 20125017 20127027 20127037 20127047 20128017 20128027 20128037 20128047 20128057 20129017 20131017 20131027…
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 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 Instruments.recalls@stryker.com. Expanded Recall: A second notification Medical Device Recall Expansion Letter letter dated 1/5/21 issued via FedEx second day to the US consignees.
Details
- Recall number
- Z-0431-2021
- Initiated
- October 16, 2020
- Posted by FDA
- November 6, 2020
- Terminated
- June 22, 2022
- Product code
- HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered)
- 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
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Portage, MI