Z-2228-2021Class II

Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01...

Name: Z-2228-2021 Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01...
Creator: Medtronic Neuromodulation
Published: 2021-06-02
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2021-06-02 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Neuromodulation began a recall of Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000 on 2021-06-02. FDA classified it as Class II and gives the reason as "Excess nylon flash on the clip". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2228-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-02
Posted: 2021-08-06
Recalling firm: Medtronic Neuromodulation
Product: Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
Product code: GXR Cover, Burr Hole
Reason for recall: Excess nylon flash on the clip.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On June 2,2021 the firm sent letter with the following information: Dear Healthcare Professional, Medtronic is voluntarily recalling specific lots of the StimLoc" Burr Hole Cover due to a manufacturing issue resulting in excess nylon flash on the clip. Please review the information contained in this letter, quarantine any affected product (see Attachment A for list of affected lot numbers) in your inventory for return to Medtronic, and sign and return the customer confirmation form included with this letter. Medtronic email at [email protected] or Medtronic Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.
Quantity in commerce: 15,192
Distribution: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and Hawaii
Product codes and lots: a) PART NUMBER: 3387S-40 - DBS Lead with StimLoc LOTS # : VA21YUS, VA24RVV, VA25SDK, VA26Q2S, VA27X8H, VA2980G, VA29Z9A, VA2DA2Z, VA21ZJU, VA24S65, VA25WK1, VA26XP2, VA27ZRF, VA29814, VA2A5MJ, VA2DA5Y, VA21ZYP, VA24S66, VA2613V, VA26ZFU, VA281L5, VA2985H, VA2AK84, VA2DA9E, VA222L5, VA24SRF, VA261EL, VA275SC, VA2820Y, VA29BSM, VA2APV8, VA2DEKH, VA227E2, VA24UVS, VA263GC, VA275SD, VA282CS, VA29E09, VA2B3PB, VA2DVM9, VA22LDZ, VA24ZFG, VA26460, VA276GS, VA283SF, VA29LP7, VA2B3PN, VA2DVME, VA236DC, VA254MA, VA2696J, VA277EB, VA28C1Z, VA29LPC, VA2B3PQ, VA2DVNX, VA23BWB, VA254MC, VA2696L, VA27JJV, VA28C36, VA29PPY, VA2BFSP, VA23BXM, VA254MD, VA269LV, VA27MQ3, VA28DVB, VA29S0E, VA2BHV6, VA23J1U, VA2562G, VA26AGU, VA27RMG, VA28LVR, VA29S0F, VA2CEVY, VA23J4X, VA257LH, VA26E5P, VA27SW9, VA28NFL, VA29SB3, VA2CPP0, VA23L21, VA25QDQ, VA26E5R, VA27V4Y, VA28NG1, VA29UNG, VA2CXDR, VA23S64, VA25RHC, VA26K1N, VA27WDK, VA28SC8, VA29UPA, VA2D9X8, VA24R3X, VA25S3A, VA26K1R, VA27WDP, VA28XL0, VA29Z98, VA2DA0S, VA23LXN, VA23WY0, VA2446L, VA24AFN, VA24FA2, VA25DKB, VA23WXZ, VA23X94, VA249A6, VA24EYN, VA2562K, VA23LXN, VA23WY0, VA2446L, VA24AFN, VA24FA2, VA25DKB, VA23WXZ, VA23X94, VA249A6, VA24EYN and VA2562K b) PART NUMBER: 3389S-28 DBS Lead with StimLoc LOTS #: VA25K4W, VA25CMZ and VA25DKD c) PART NUMBER: 3389S-40 - DBS Lead with StimLoc LOTS #: VA21X0Y, VA24WXJ, VA260NN, VA27QE4, VA28NFM, VA29ZU0, VA2BE8A, VA2CQET, VA21ZJV, VA25101, VA26233, VA27RET, VA28SCE, VA2A3HK, VA2BEXC, VA2CQFM, VA21ZL1, VA259WX, VA2670U, VA27REU, VA28URD, VA2A6K7, VA2BF1G, VA2CQH2, VA227NQ, VA25B79, VA2672S, VA27SWB, VA28URE, VA2ACW4, VA2BFG0, VA2CRKW, VA228PU, VA25HSZ, VA26GGZ, VA27V8S, VA28XHX, VA2ACW5, VA2BHHW, VA2D6WD, VA22C6L, VA25N4Y, VA26GPA, VA27WDE, VA28ZQ0, VA2AD57, VA2BJEH, VA2D71G, VA22KF4, VA25N50, VA26KJ3, VA27ZA2, VA28ZQ2, VA2AD5G, VA2C8BG, VA2D730, VA22MXM, VA25N6D, VA26NWG, VA27ZRE, VA291YL, VA2AH9C, VA2CABX, VA2D739, VA22TDL, VA25RSZ, VA26Q16, VA280V2, VA291YM, VA2AHHR , VA2CBQ0, VA2D73E, VA22V9R, VA25TBA, VA26Q6E, VA283SH, VA2924E, VA2AHNG, VA2CFBH, VA2DAZA, VA22VZB, VA25UBK, VA26R4H, VA2865T, VA2924F, VA2AHNM, VA2CJ4Z , VA2DAZT, VA22Y79, VA25UG1, VA26TK5, VA2893X, VA29LPD, VA2AHT7, VA2CK66, VA2DB2C, VA237AP, VA25VKR, VA26XGF, VA289WG, VA29LUC, VA2AR36, VA2CK8L, VA2DB2L, VA2382J, VA25VQD, VA26ZFV, VA289WH, VA29MUW, VA2B3SB, VA2CLRF, VA2DB2V, VA2382Y, VA25XC7, VA272ZP, VA28DN6, VA29PLU, VA2B3SC, VA2CN0F, VA2DBAU, VA2384E, VA25YHU, VA275D6, VA28E06, VA29PM8, VA2B7G5, VA2CN0H, VA2DUR8, VA239JK, VA25YHW, VA276MJ, VA28KWJ, VA29UB3, VA2BDS1, VA2CN7Z, VA2DUR9, VA23P6D, VA25YR5, VA27E9P, VA28LHR, VA29UPD, VA2BDSE, VA2CN86, VA2DURH, VA23S5Z, VA25ZJ3, VA27JJS, VA28LHU, VA29UPH, VA2BDSX, VA2CN8A, VA24PD4, VA25ZJ6, VA27K8D, VA28M21, VA29ZES, VA2BE44, VA2CNX0, VA24RVR, VA25ZUB, VA27NE2, VA28M22, VA29ZM2, VA2BE7W, VA2CNXG, VA24WXH, VA25ZWB, VA27PDB, VA28M9B, VA29ZSC, VA2BE86, VA2CPPV, VA23MM7, VA23TVY, VA240PB, VA24237, VA2493U, VA24EYM, VA24L0S VA25LHE, VA23S65, VA23WXW, VA240YK, VA2440E, VA2493V, VA24G61 VA24M5P, VA25PZU, VA23TFY, VA23X95, VA241H1, VA244QV, VA24A58, VA24G7S, VA25B78, VA25QSW, VA23TVT, VA23XYL, VA241NE, VA245W8, VA24AYZ, VA24GWZ and VA25CF3 d) PART NUMBER: 3391S-40 - DBS Lead with StimLoc LOTS #: VA2391V, VA25B91, VA2AD6N, VA2BJWK, VA2DN50 and VA2DR23 e) PART NUMBER: 3550S-01 - Spare Parts Kit for StimLoc¿ Burr Hole Cover LOTS #: 082300620, 082307020, 082307620, 082329819, 082332919, 082335119, 082335320, 82316820 and 82326919 f) PART NUMBER: 924256 - StimLoc Burr Hole Cover LOTS #: 082202020A, 082203820A, 082211120A, 082228819A, 082234520A, 082202121A, 082207920A, 082214120A, 082232319A, 082235019A and 082224219A g) PART NUMBER: DB-5000 -StimLoc Support Clips LOTS #: 082104420

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2228-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2228-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-18	2021-08-06

Product code GXR

K001096Class IIBurr Hole Cover, Model XxImage-Guided Neurologics, Inc. / cleared 2000-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)