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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Zyphr Disposable Cranial Perforator

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  Class 2 Device Recall Stryker Zyphr Disposable Cranial Perforator see related information
Date Initiated by Firm October 16, 2020
Date Posted November 06, 2020
Recall Status1 Terminated 3 on June 22, 2022
Recall Number Z-0431-2021
Recall Event ID 86670
510(K)Number K082010  
Product Classification Drills, burrs, trephines & accessories (compound, powered) - Product Code HBF
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
Code Information 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 20131037 20134017 20134027 20136017 20136027 20136037 20136047 20136057 20136067 20136077 20139017 20139027 20139037 20141017 20141027 20141037 20141047 20142017 20142027 20142037 20142047 20143017 20143027 20146017 20146027 20147017 20147027 20147037 20147047 20148017 20148027 20148037 20150017 20150027 20150037 20150047 20154017 20154027 20155017 20155027 20155037 20156017 20157017 20157027 20157037 20161017 20162017 20162027 20164017 20167017 20167027 20168017 20168027 20168037  20171017 20171027 20171037 20171047 20171057 20171067 20171077 20171107 20177017 20177027 20177037 20178017 20178027 20178037 20189017 20189027 20189037 20189047 20189057 20189067 20190017 20190027 20192017 20195037 20197017 20199027 20199037 20199047 20199057 20199067 20202017 20202027 20203017 20203027 20203037 20204017 20204027 20204037 20204047 20206017 20206027 20206037 20206047 20206057 20206067 20211017 20211027 20211037 20211047 20217017 20217027 20217037 20220017 20220027 20220037 20220047 20220057  Expanded Recall 1/5/21: 20220067 20220077 20227027    
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact SAME
269-501-8375
Manufacturer 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 2		 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 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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HBF and Original Applicant = STRYKER IRELAND LTD., INSTRUMENTS DIVISION
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