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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98341

17 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 23, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
I.T.S. GmbH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

17 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 17

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

Z-1592-2026
Recall number
Z-1592-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
220 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

Article Number (Lot Numbers): 21031-3 (679/042207, 679/032240, 679/0323115, 679/052317, 26/F70606, 679/032253, 643/032501, 643/072503, 643/102501), 21031-5 (43/0015, 643/102201, 643/102201, 679/0323121, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 643/102201, 643/102201, 643/102201, 643/102201, 679/0323120, 679/0323120), 21032-11 (679/112312), 21032-3 (679/032241, 643/0623, 679/042293, 679/0323122, 679/062367, 679/052318, 643/022501, 643/062501, 643/072501, 643/102502), 21032-5 (679/122136, 679/0323143, 679/042337), 21033-3 (679/062212, 679/022301, 679/042338, 679/022302), 21033-5 (643/0629, 26/F24901, 679/012311), 21034-3 (679/062221, 679/012312, 679/072217, 679/042339), 21034-5 (643/102202, 679/012314, 679/012313), 21035-3 (679/062222, 679/042308, 643/012501, 643/0548), 21036-3 (679/062213, 679/042309, 679/112317),

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 2 of 17

Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

Z-1593-2026
Recall number
Z-1593-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
322 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 21116-8 (679/092230), 21117-10 (679/032313, 679/092231), 21118-10 (679/032314, 679/072047, 679/092232). 2. Article Number (Lot Numbers): 21121-6 (679/092236, 679/092329), 21121-8 (679/052226). 3. Article Number (Lot Numbers): 21122-10 (00/0425-02, 00/0825-02, 679/022443, 679/062310, 86/043372), 21122-6 (00/0325-01, 00/0425-01, 679/042340, 679/062334, 679/122269, 86/043366), 21122-8 (00/0325-08, 679/022243, 679/022304, 679/022451, 679/042209, 679/042214, 679/052319, 679/102368, 86/043368). 4. Article Number (Lot Numbers): 21123-4 (00/0810-06, 679/052014, 679/062216), 21124-4 (679/042333, 679/062217, 679/072346), 21127-6 (679/052228), 21128-6 (679/042341).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 3 of 17

Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.

Z-1594-2026
Recall number
Z-1594-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
292 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

Article Number (Lot Numbers): 211341-10 (26/F63368, 26/F65625, 26/F66904, 26/F669041, 679/012410), 211341-4 (26/F63366, 26/F65626, 26/F656261, 26/F66145, 26/F661451, 26/F66496, 26/F66905, 26/F669051, 26/F73497, 679/012439, 679/022450), 211341-7 (26/F63367, 26/F65627, 26/F66146, 26/F66906, 679/012440), 21134-4 (768/18758, 768/19642), 21134-5 (778/201904), 21135-4 (26/F67801, 768/21382), 21136-4 (26/F65629, 26/F66907, 26/F67802, 26/F70071, 768/21383), 21136-5 (770/101901), 21136-7 (26/F65039, 26/F65630), 21137-4 (26/F65631, 26/F67804, 768/21384), 21137-7 (26/F65040), 21138-4 (26/F65633, 26/F66908, 26/F67806), 21139-4 (26/F65634, 26/F67807, 768/21386).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 4 of 17

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

Z-1595-2026
Recall number
Z-1595-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

Article Number (Lot Numbers): 21064-60 (679/012318, 679/0722100).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 5 of 17

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

Z-1596-2026
Recall number
Z-1596-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
101 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 21311-11 (26/F62573), 21311-15 (26/F65048, 26/F67521), 21311-7 (26/F66165, 26/F67825), 21312-11 (26/F65049, 26/F67826), 21312-15 (26/F66166), 21312-7 (26/F65643, 26/F67827). 2. Article Number (Lot Numbers): 21094-10 (643/032304, 643/082309), 21094-4 (643/0572, 643/0571), 21094-6 (643/112202), 21094-8 (643/012309). 3.Article Number (Lot Numbers): 21093-4 (679/032311, 679/112331), 21093-6 (679/112332).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 6 of 17

Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.

Z-1597-2026
Recall number
Z-1597-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
70 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1 Article number (Lot Numbers): 21112-7 (643/0549), 21114-5 (643/032301, 643/042303, 643/042304, 643/0618, 643/102211, 643/112304), 21113-9 (643/072320). 2. Article number (Lot Numbers): 21111-6 (643/032306, 643/072319, 643/112201), 21111-8 (643/032318), 21111-12 (643/032305).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 7 of 17

I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

Z-1598-2026
Recall number
Z-1598-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
510 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 21604-6 (643/052301, 643/0652, 643/092201), 21604-9 (643/032311, 643/062308, 643/062309, 643/112310, 643/122201). 2. Article Number (Lot Numbers): 21605-11 (643/072314, 643/102207), 21605-6 (643/0654, 643/072306, 643/072316, 643/072338, 643/102208, 643/102212, 643/102217, 643/112306, 643/122202), 21605-9 (643/0643, 643/0662, 643/072307, 643/072339, 643/112309, 643/122203). 3. Article Number (Lot Numbers): 21105-6 (86/876787), 21105-8 (86/876788). 4. Article Number (Lot Numbers): 21104-4 (679/052234, 679/082305, 86/036334), 21104-5 (679/0722101, 679/082306, 86/036335), 21104-6 (679/012307, 86/876760), 21104-7 (679/082307, 86/036336, 86/876781), 21104-8 (679/082308, 86/876783), 21104-9 (86/876904). 5. Article Number (Lot Numbers): 21101-5 (86/876637), 21101-6 (679/121605, 00/1105-12, 26/F41923, 86/876638, 86/903610), 21101-7 (770/201905, 00/0518-06, 679/042303, 86/876640), 21101-8 (86/876721, 679/062224), 21101-9 (679/122264, 86/876727), 21101-11 (86/876633), 21101-13 (86/876635). 6. Article Number (Lot Numbers): 21102-6 (770/201905). 7. Article Number (Lot Numbers): 21103-8 (679/092216), 21103-9 (679/062215, 86/876758), 21103-10 (679/092219, 86/876741), 21103-11 (679/062214), 21103-12 (86/876743), 21103-13 (679/022303, 86/876745).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 8 of 17

I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

Z-1599-2026
Recall number
Z-1599-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
5,568 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 31404-16 (679/062339, 679/122213, 679/122332), 31404-18 (679/122212, 679/062340), 31404-20 (18/089221, 679/062343, 679/122241), 31404-22 (18/061535, 679/012416, 679/062350), 31404-24 (18/071536, 679/062362, 679/122246), 31404-26 (679/122245, 679/062363), 31404-28 (18/186278, 679/062364), 31404-30 (18/187299, 679/012401, 679/062365, 679/122242), 31404-32 (18/111540, 679/062366, 679/122211), 31404-34 (679/122206, 18/121544, 679/012402, 679/042414, 679/072302, 679/122206), 31404-36 (18/188300, 679/052403, 679/072305, 679/112223), 31404-38 (18/189301, 679/112213, 679/012455, 679/072309), 31404-40 (18/181043, 679/062321, 679/122201, 679/122310, 679/052404, 679/032532), 31404-42 (679/122203, 18/191303, 679/072310, 679/012418, 679/052424, 679/052505), 31404-44 (18/192304, 679/112232, 679/052332, 679/052425, 679/052508), 31404-46 (679/122240, 679/062322, 679/112210, 679/052426, 679/042505), 31404-48 (679/052427, 679/072317, 679/122248), 31404-50 (18/194306, 679/112228, 679/062301, 679/122311, 679/052406, 679/052413, 679/042506, 679/062501), 31404-55 (18/195307, 679/122258, 18/211647, 679/072326, 679/012452, 679/062467, 679/062511), 31404-60 (18/196308, 679/112240, 679/052325, 679/122312, 679/062485, 679/062512), 31404-65 (679/122259, 679/072327, 18/205310, 679/022410), 31404-70 (679/012301, 18/197309, 679/072328, 679/022413, 679/062479), 31404-75 (18/205411, 18/381989, 679/012302), 31404-80 (18/172638, 18/205232, 18/321164, 679/022416), 31457-30 (26/F50332), 31457-36 (18/198343), 31457-40 (18/199344), 31457-46 (18/947783, 18/736681), 31457-50 (18/201346, 26/F67796), 31457-55 (18/202347, 26/F67797), 31457-60 (18/203355), 31652-100 (679/122117, 679/022350, 679/102335, 679/022335, 18/924999), 31652-105 (679/022336, 679/032377), 31652-110 (679/032380, 679/102339), 31652-115 (679/102336), 31652-120 (679/092002, 679/102347), 31652-25 (679/112134, 679/032340), 31652-30 (679/032341), 31652-35 (679/082315), 31652-40 (679/082316), 31652-45 (679/032330, 679/092332), 31652-55 (679/032391, 679/092333), 31652-60 (679/022337, 679/032378, 679/092336), 31652-65 (679/022338, 679/032322, 679/092347), 31652-70 (679/032320, 679/032365, 679/042405, 679/112154), 31652-75 (26/F65330, 679/032348, 679/032386), 31652-80 (679/112181, 679/032321, 679/092350, 679/032362, 679/092348, 679/042410, 18/920995), 31652-85 (679/122145, 679/032382, 679/022349, 679/102301, 679/102305, 679/042411, 18/541045), 31652-90 (679/012201, 679/032383, 679/032383, 679/022347, 679/042406), 31652-95 (18/923998, 679/012202, 679/032316), 31731-100 (18/775943, 26/F58803, 679/102420), 31731-105 (18/776944, 26/F58804, 26/F65649, 679/102421), 31731-110 (26/F58805, 26/F65650, 679/102422), 31731-115 (26/F58806, 26/F65651, 679/102423), 31731-120 (26/F58807, 26/F65652, 679/102436), 31731-50 (09/1244, 26/F14488, 26/F21185, 26/F58793), 31731-60 (26/F58795, 26/F65655), 31731-65 (26/F65656, 26/F58796), 31731-70 (26/F58797, 26/F65657), 31731-75 (26/F58798, 26/F65658), 31731-80 (679/072040, 26/F58799, 26/F65659), 31731-85 (18/331317, 26/F65660, 679/072044), 31731-90 (09/1247, 09/1248, 26/F58801, 26/F65661, 46/612), 31731-95 (18/581247, 26/F58802, 26/F65662, 679/102437), 31732-60 (18/961265), 31734-100 (26/F65672), 31734-105 (26/F58839, 26/F65673), 31734-110 (26/F58840, 26/F65674, 679/032425), 31734-115 (26/F65675), 31734-120 (26/F58842, 26/F65676, 26/F72277), 31734-45 (18/761192), 31734-50 (26/F58828, 26/F65680), 31734-60 (26/F58830), 31734-65 (26/F58831, 26/F65683, 679/032428), 31734-70 (26/F58832, 26/F65684, 26/F72275, 679/032429), 31734-75 (26/F58833, 26/F65685), 31734-80 (26/F58834, 26/F65686, 679/032435), 31734-85 (26/F58835, 26/F65687, 26/F72276), 31734-90 (26/F65688, 679/032436), 31734-95 (26/F58837, 26/F65689, 679/042401). 2. Article Number (Lot Numbers): 31277-18 (26/F36049), 31357-20 (18/091247), 31357-22 (679/031707), 31357-24 (86/485378), 31357-26 (18/121250), 31357-28 (26/F65909), 31357-30 (18/165201, 18/341054), 31357-32 (18/166217), 31357-34 (18/167218), 31357-36 (18/168219, 26/F65910), 31357-38 (18/167220), 31357-40 (26/F65911, 18/170221), 31357-42 (26/F65912), 31357-44 (18/171222, 18/361059, 26/F65913), 31357-46 (18/861060), 31357-48 (18/172223, 26/F65914), 31357-60 (26/F65648), 31357-65 (679/012125), 31357-70 (18/902013). 3. Article Number (Lot Numbers): 36851 (26/F59918, 26/F61351, 26/F64885, 26/F64886, 26/F65908, 26/F66506, 26/F71413, 26/F71764, 26/F72364, 26/F73020, 26/F74288). 4. Article Number (Lot Numbers): 36432 (26/F65379, 26/F67799, 26/F72744, 774/300002), 36653 (26/F62590, 26/F68455), 36732 (26/F67800). 5. Article Number (Lot Numbers): 36431 (26/F62589, 26/F65378, 26/F66505, 26/F67798, 26/F70092, 26/F72743, 26/F73017, 26/F73494), 36651 (26/F61694, 26/F65380, 26/F68454, 26/F73018), 36653 (26/F73019), 36731 (26/F60987, 26/F62591, 26/F67523, 26/F70093, 26/F72363, 26/F73495).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 9 of 17

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

Z-1600-2026
Recall number
Z-1600-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 10 of 17

I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.

Z-1601-2026
Recall number
Z-1601-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
869 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 21602-3 (643/072330, 643/092310), 21602-4 (643/072301, 643/072308), 21602-5 (643/022417, 643/0650, 643/072309), 21602-6 (643/042305, 643/072333), 21602-7 (643/072332, 643/082305), 21602-8 (43/0405, 643/012305), 21603-3 (643/072331, 643/082306), 21603-4 (643/102214, 643/102206, 643/072302, 643/022313, 643/032310), 21603-5 (643/072335, 643/122308), 21603-6 (643/022309, 643/072305, 643/072311, 643/122309), 21603-7 (643/072337, 643/082313), 21603-8 (643/072312, 643/122204). 2. Article Number (Lot Numbers): 21225-4 (768/20894, 26/F65041, 26/F66149, 679/092305, 679/022430, 26/F705141, 26/F72362, 26/F73634), 21225-6 (768/20895, 768/20039, 26/F65042, 26/F66150, 26/F66499, 679/092321, 26/F705161, 679/062459, 26/F70516, 26/F73635), 21225-8 (768/20896, 26/F65635, 26/F66500, 26/F70515), 21225-10 (26/F66497), 21225-12 (26/F66498, 679/012438), 21226-4 (26/F65043, 26/F66152, 26/F66501, 26/F70521, 26/F705211, 679/012412, 679/062306, 679/092306, 768/20897, 768/208978), 21226-6 (26/F35433, 26/F65044, 26/F66502, 26/F70522, 26/F705221, 679/062307, 679/092307, 768/20898), 21226-8 (26/F66503, 679/012413, 768/20045, 768/20899), 21226-10 (26/F66151), 21226-12 (26/F66148, 679/012411). 3. Article Number (Lot Numbers): 21601-5 (643/012302, 643/072323), 21601-6 (643/072326, 770/201904), 21601-7 (643/012303, 643/022308, 643/0647, 643/072315, 643/072327, 643/082303), 21601-8 (643/072328, 643/072329), 21601-10 (643/022312, 643/082301, 643/082302), 21601-12 (26/F70342), 21601-14 (26/F70343), 21601-16 (26/F70344).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 11 of 17

Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.

Z-1602-2026
Recall number
Z-1602-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
12,059 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 37351-10-N (18/240314, 679/122205), 37351-12-N (18/200330, 18/943977, 26/F65544, 679/032401, 679/052417, 679/122261), 37351-14-N (18/201331, 18/511504, 18/944978, 26/F65545, 679/032402, 679/032514, 679/052244, 679/052418, 679/052516, 679/072520), 37351-16-N (18/202332, 18/521505, 18/945979, 26/F65163, 679/032423, 679/032504, 679/052201, 679/062466, 679/062504, 679/072521, 679/122251), 37351-18-N (18/203333, 18/531506, 18/946980, 18/971215, 26/F65546, 679/022329, 679/022516, 679/032430, 679/062206, 679/062505, 679/072522), 37351-20-N (18/231334, 18/541507, 18/952981, 26/F65164, 26/F65547, 679/032431, 679/062230, 679/072501, 679/122202), 37351-22-N (18/233335, 18/953982, 26/F65548, 679/062233, 679/092111, 679/122210), 37351-24-N (18/238336, 18/956983, 26/F65549, 679/042415, 679/072203, 679/112242), 37351-26-N (18/204337, 18/947984, 26/F65166, 26/F65550, 679/022330, 679/042416, 679/062207), 37351-28-N (18/234338, 18/954985, 26/F65551, 679/022331, 679/042423, 679/072204), 37351-30-N (18/205339, 18/948986, 26/F65552, 679/042424, 679/072205, 679/122209), 37351-32-N (18/235340, 18/955987, 26/F65553, 679/042425, 679/062234), 37351-34-N (18/206341, 18/491108, 26/F65554, 679/012306, 679/042426, 679/062208), 37351-36-N (18/239342, 18/571109, 18/571503, 26/F65555, 679/022324, 679/052401, 679/062209), 37351-38-N (18/230679, 18/501110, 18/862696, 679/052402, 679/122252), 37351-40-N (147/15088L, 18/207343, 18/506128, 18/511111, 679/052411), 37351-42-N (18/581112, 679/032515), 37351-44-N (18/591113, 679/022511), 37351-46-N (18/601114), 37351-48-N (18/611115, 679/032517), 37351-50-N (18/513248, 18/621116, 18/912703, 679/032518, 679/062508), 37351-55-N (18/652407, 679/032519), 37351-60-N (18/662408), 37351-65-N (679/022512, 679/052236), 37351-70-N (18/631117, 679/052237), 37351-75-N (18/641118, 679/052238), 37351-80-N (679/052239, 679/072406), 37351-85-N (679/052240). 2. Article Number (Lot Numbers): 21241-5 (770/201905), 21241-7 (770/201906), 21242-7 (770/201901), 21243-10 (770/201901), 21244-9 (770/201905).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 12 of 17

I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

Z-1603-2026
Recall number
Z-1603-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
176 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 21301-5 (26/F62569), 21301-7 (26/F62570), 21301-9 (26/F67518), 21301-13 (26/F62568, 26/F67815), 21302-5 (26/F67520), 21302-7 (26/F67821), 21302-9 (26/F62572, 26/F67822), 21302-13 (26/F62571, 26/F67519, 26/F67820). 2. Article Number (Lot Numbers): 21321-7 (26/F54955, 26/F62576), 21321-12 (26/F55883), 21322-7 (26/F55890, 26/F62578), 21322-12 (26/F62577). 3. Article Number (Lot Numbers): 21325-4 (26/F70528, 679/022433, 679/032217, 679/102240, 679/102242, 679/102303), 21325-7 (679/102241, 679/102304).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 13 of 17

I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

Z-1604-2026
Recall number
Z-1604-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), 21232-6 (26/F62564, 26/F65638), 21233-3 (26/F65639), 21233-4 (26/F65640), 21233-6 (26/F61723, 26/F65046), 21234-4 (26/F65641, 26/F66504), 21235-4 (26/F65642, 26/F67810). 2. Article Number (Lot Numbers): 21231-6 (643/012301, 643/022310, 643/032308, 643/0630, 643/0657, 643/102402, 643/122301). 3. Article Number (Lot Numbers): 37302-18 (18/636447), 37302-20 (18/802189).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 14 of 17

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

Z-1605-2026
Recall number
Z-1605-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
15,517 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 37303-10 (18/151720, 18/268729, 679/032432, 679/072268, 679/102237, 679/102307), 37303-12 (18/570637, 679/032434, 679/072269, 679/102346, 679/112227), 37303-14 (18/751091, 26/F66913, 679/012510, 679/062288, 679/102359, 679/112410), 37303-16 (679/072263, 679/102245, 18/151841, 26/F66914, 18/331193, 18/543625, 679/012511, 679/042403, 679/102360), 37303-18 (18/151942, 18/210467, 18/231415, 18/341194, 18/572633, 18/771093, 679/012512, 679/022507, 679/042404, 679/102248, 679/112319), 37303-20 (18/152043, 18/211468, 18/351195, 18/573634, 18/701585, 18/781094, 679/022508, 679/042420, 679/112216, 679/112328), 37303-22 (18/171705, 18/212469, 18/361196, 18/574635, 18/791095, 679/022509, 679/042417, 679/112224, 679/112340), 37303-24 (18/575639, 18/741572, 26/F66915, 679/022510, 679/112226, 679/122313, 679/122333), 37303-26 (18/152346, 18/214471, 26/F66916, 679/012403, 679/112230, 679/122323), 37303-28 (26/F66917, 679/112231, 679/122328), 37303-30 (18/192716, 18/591743, 679/122334). 2. Article Number (Lot Numbers): 32271-10 (18/061949, 18/231167, 679/062351), 32271-12 (18/048927, 26/F66235, 679/042215, 679/062342, 679/062405, 679/062489, 679/072271), 32271-14 (18/049928, 18/231165, 26/F66140, 679/042210, 679/052340, 679/052518, 679/062471, 679/062490, 679/072267), 32271-16 (18/231164, 18/311125, 26/F66141, 679/042216, 679/052519, 679/062315, 679/062483, 679/072272, 679/072401), 32271-18 (18/062950, 26/F65556, 26/F66236, 679/032261, 679/062332, 679/072402), 32271-20 (18/063951, 26/F66237, 679/052326), 32271-22 (18/064952, 26/F65557, 679/032263, 679/062354), 32271-24 (18/065953, 26/F65558, 679/062333), 32271-26 (679/032265), 32271-28 (26/F65559, 679/062357, 679/052520), 32271-32 (26/F65561), 32271-34 (26/F65562). 3. Article Number (Lot Numbers): 37304-10 (18/635486, 26/F24799, 679/012419, 86/011176), 37304-12 (18/061352, 18/521172, 18/5211721, 18/576643, 18/630487, 679/012433, 679/092207, 679/122409), 37304-14 (18/081360, 18/531173, 18/5311731, 18/577644, 18/631488, 679/012434, 679/092208, 679/122410), 37304-16 (18/541174, 18/578645, 18/632489, 679/012444, 679/092201, 679/122411), 37304-18 (18/092020, 18/551175, 18/633490, 679/022403, 679/092202), 37304-20 (18/011320, 18/561176, 18/634491, 679/012287, 679/012420, 679/082217, 86/483331), 37304-22 (18/241273, 679/012288, 679/012421), 37304-24 (18/021321, 18/571177, 679/012289, 679/012445). 4. Article Number (Lot Numbers): 21413-6 (26/F52124). 5. Article Number (Lot Numbers): 21431-ME (679/102045). 6. Article Number (Lot Numbers): 21482 (679/092020), 21483 (26/F55902). 7. Article Number (Lot Numbers): 21421-5 (26/F65377, 679/092039). 8. Article Number (Lot Numbers): 37241-10 (18/012169, 18/610104, 18/701013), 37241-12 (18/231295, 18/767108), 37241-14 (18/511016, 18/537392, 26/F24807, 679/012280), 37241-16 (18/005340, 18/121106, 18/231387, 18/521017, 18/560517), 37241-18 (18/232328, 18/531018, 679/072408, 86/311848), 37241-20 (18/233388, 18/541020, 18/562519, 679/072419, 86/287847), 37241-22 (18/066109, 18/234389, 18/551021, 26/F24594, 26/F24811), 37241-24 (18/561022, 18/564521, 18/608110, 26/F24595), 37241-26 (18/611111, 18/711023, 26/F24596, 26/F24813), 37241-28 (18/612112, 18/721024, 18/811597, 26/F24597, 86/485508), 37241-30 (18/015172, 18/613113, 18/731019, 26/F24598). 9. Article Number (Lot Numbers): 21015-08 (00/0123-12, 00/0321-43, 00/0723-07), 21015-09 (00/0123-13).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 15 of 17

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

Z-1606-2026
Recall number
Z-1606-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
623 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

Article Number (Lot Numbers): 31207-10 (679/112002), 31207-12 (679/092133, 679/102343, 679/112006), 31207-14 (679/102050), 31207-16 (679/102345, 679/102049), 31207-18 (679/0323110, 679/102355, 679/112001), 31207-20 (679/0323111, 679/102051, 679/102356), 31207-24 (679/102028), 31207-26 (679/112008), 31207-28 (679/112009), 31207-30 (679/0323140, 86/483377), 31257-12 (679/081904), 31257-14 (679/042323, 679/081905), 31257-16 (679/042324), 31257-18 (679/112308, 679/022128), 31257-20 (679/022123, 679/042326, 679/112321), 31257-22 (679/022124, 679/042327, 679/112325), 31257-24 (679/022125, 679/112326), 31257-28 (679/022130, 679/052306), 31257-30 (679/022131), 31307-18 (679/061907), 31307-32 (679/062285), 31307-34 (679/062286), 31307-36 (679/062287), 31307-38 (679/032118), 31358-30 (26/F67790), 31437-30 (679/071916), 31437-38 (679/071918), 31437-40 (679/032406, 679/071903), 31437-50 (679/071920), 31757-100 (35/51892), 31757-120 (86/320792), 31757-45 (86/320793), 31757-80 (26/F55872), 31757-85 (26/F55873), 31757-90 (26/F55874).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 16 of 17

HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.

Z-1607-2026
Recall number
Z-1607-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
1,307 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 32151-6 (18/408462, 18/500495, 18/691266), 32151-8 (18/408866, 18/531370), 32151-9 (18/351668, 18/541373, 18/741269), 32151-10 (18/408986, 18/551374), 32151-11 (18/371670, 18/561375), 32151-12 (18/409087, 18/571376, 18/771272), 32151-13 (18/581377), 32151-14 (18/409289, 18/591378, 18/791274), 32151-15 (18/409390), 32151-16 (18/409491), 32151-18 (18/821277), 32151-20 (18/831278). 2. Article Number (Lot Numbers): 21505-4 (86/350493, 86/677353), 21506-4 (86/642718, 86/677157). 3. Article Number (Lot Numbers): 21507-4 (26/F65050), 21508-4 (26/F63934, 86/677180). 4. Article Number (Lot Numbers): 21517 (26/F66911). 5. Article Number (Lot Numbers): 21502 (86/677136), 21503-4 (86/337934), 21503-6 (86/868870), 21503-8 (26/F63936), 21503-10 (86/337896, 86/677146), 21504-6 (26/F63364, 86/868885), 21504-8 (26/F63365), 21504-10 (86/642711, 86/677154). 6. Article Number (Lot Numbers): 21513-3 (86/677385), 21513-5 (86/677389), 21514-3 (26/F63935), 21514-5 (86/642722, 86/677183, 86/869183). 7. Article Number (Lot Numbers): 37151-5 (18/561228), 37151-8 (18/166019), 37151-9 (18/625633), 37151-10 (18/626634), 37151-12 (18/628636, 18/671232), 37151-13 (18/166423), 37151-15 (18/206189), 37151-16 (18/132035, 18/691234), 37151-18 (18/142036), 37151-24 (18/167068, 18/172039), 37251-8 (18/421197), 37251-9 (18/591223), 37251-11 (18/619644), 37251-12 (18/620645, 18/962052), 37251-13 (18/521703), 37251-14 (18/531704, 18/951141), 37251-16 (18/002056, 18/031952, 18/623648, 18/971143), 37251-20 (18/571708, 26/F61731).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

device · product 17 of 17

Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90. 6. Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200. 7. Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32. 8. Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90. 9. Curved Plate; Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20. 10. Posterior Column Plate, Left; Article Numbers: 212121-6. 11. Posterior Column Plate, Right; Article Numbers: 212131-6. 12. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-SM. 13. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-LA. 14. Posterior Wall Plate, Extended, Right; Article Numbers: 212111-LA, 212111-SM. 15. Posterior Wall Plate, Left; Article Numbers: 212141-7, 212141-8. 16. Posterior Wall Plate, Right; Article Numbers: 212151-7, 212151-8. 17. PRS Plate; Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7. 18. Quadrilateral Buttress Plate; Article Numbers: 21208-13, 21209-13. 19. Quadrilateral Buttress Plate; Article Numbers: 21208-11, 21209-11. 20. Rim Plate, Left; Article

Z-1608-2026
Recall number
Z-1608-2026
Initiated
January 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
46,637 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information

1. Article Number (Lot Numbers): 21218-16 (679/112166, 679/122229, 679/122230, 679/122304), 21219-16 (679/012441, 679/062456, 679/0624561, 679/112167, 679/122228). 2. Article Number (Lot Numbers): 21218-14(679/032417, 679/102231, 679/112158, 679/112164, 679/122231), 21219-14 (679/012505, 679/112159, 679/112165, 679/122227, 679/122305). 3. Article Number (Lot Numbers): 21216-10 (679/032501, 679/062453, 679/072276, 679/072510, 679/092203, 679/092401, 679/112168, 679/112409, 679/122270), 21216-12 (679/032503, 679/062344, 679/062454, 679/072277, 679/092204, 679/112170, 679/112413, 679/122271), 21217-10 (679/032502, 679/062346, 679/072278, 679/092402, 679/092404, 679/102216, 679/112169, 679/112423), 21217-12 (679/022238, 679/062345, 679/072513, 679/092403, 679/112171, 679/122407, 679/122426). 4. Article Number (Lot Numbers): 30591-36 (18/922090), 30591-70 (18/231539, 18/775273), 30591-75 (18/751307), 30591-80 (18/777295), 30591-85 (18/301308), 30591-90 (18/311309). 5. Article Number (Lot Numbers): 37422-12-N (18/145897, 18/461842), 37422-14-N (18/215281, 679/032001, 679/062320, 679/092355, 679/122326), 37422-16-N (679/052229, 679/052307, 679/102214, 679/102306, 679/122329), 37422-18-N (18/240520, 18/452529, 18/473354, 679/052316, 679/102215, 679/102337, 679/122330), 37422-20-N (679/0323147, 679/072306, 679/102211, 679/102338, 679/122331), 37422-22-N (18/092876, 18/543636, 679/012406, 679/062361, 679/072312, 679/102212, 679/102348), 37422-24-N (679/012407, 679/052333, 679/072313, 679/102349), 37422-26-N (679/012435, 679/062316, 679/072322, 679/102353), 37422-28-N (18/192499, 679/012422, 679/032211, 679/062317, 679/062323, 679/072323, 679/102361), 37422-30-N (18/217289, 679/012436, 679/032212, 679/0323142, 679/072324, 679/102354), 37422-32-N (18/218290, 679/012437, 679/052335, 679/052337, 679/072329, 679/112306), 37422-34-N (18/031830, 18/219291, 679/012446, 679/062337, 679/062341, 679/072330, 679/112318), 37422-36-N (18/220292, 18/240540, 18/734742, 679/012447, 679/042317, 679/042321, 679/062003, 679/072334, 679/102361), 37422-38-N (18/105881, 18/221293, 18/362296, 18/412482, 679/012243, 679/022407, 679/052331, 679/052334, 679/072349, 679/112323), 37422-40-N (18/052830, 18/222294, 18/240538, 18/493069, 18/736744, 679/022401, 679/032310, 679/042302, 679/072354, 679/112329), 37422-42-N (18/053831, 18/081544, 18/223295, 18/364298, 18/733745, 679/022402, 679/062371, 679/082304, 679/112330), 37422-44-N (18/054832, 18/224296, 18/365299, 18/737746, 18/781832, 679/022412, 679/042331, 679/042345, 679/082314, 679/112335), 37422-46-N (18/052578, 18/225314, 18/366300, 18/738747, 679/022419, 679/042313, 679/042318, 679/082319, 679/112336), 37422-48-N (18/056834, 18/226315, 679/022423, 679/052324, 679/052328, 679/072316, 679/092314, 679/112337), 37422-50-N (18/227316, 18/740748, 679/022436, 679/042336, 679/052314, 679/092342, 679/112338), 37422-55-N (18/113882, 18/368302, 679/032215, 679/052336, 679/062309, 679/092322, 679/112324), 37422-60-N (18/229318, 18/240517, 18/927095, 28/33034, 679/032403, 679/062349, 679/062351, 679/092325, 679/122307), 37422-65-N (18/118884, 18/230319, 18/271754, 18/743749, 18/761192, 28/35846, 679/032216, 679/072303, 679/092326, 679/122308), 37422-70-N (679/102213, 18/744750, 18/893916, 679/062368, 679/092338, 679/102213, 679/122309), 37422-75-N (18/122888, 18/231839, 679/072304, 679/122306), 37422-80-N (679/122254, 18/124887, 679/062352, 679/122320), 37422-85-N (18/056936, 18/271837, 679/012256, 679/092339), 37422-90-N (18/050600, 18/321273, 679/092340), 37422-95-N (18/130891, 679/092341), 37422-100-N (18/132892, 18/341607, 679/102403), 37422-105-N (679/102404), 37422-110-N (18/136894, 18/371843, 679/092337), 37422-115-N (18/138895, 18/391845, 679/012262), 37422-120-N (18/140896, 679/092349), 37592-18 (679/072351), 37592-20 (18/831792, 18/252862), 37592-22 (18/172773, 679/072356), 37592-24 (679/082301), 37592-26 (18/182774, 679/082303), 37592-28 (679/012140, 679/082310), 37592-30 (18/112775, 679/082317), 37592-32 (679/082312), 37592-34 (18/192863, 679/082313), 37592-36 (679/082318), 37592-38 (679/092308), 37592-40 (679/052116, 679/072314), 37592-42 (679/092310), 37592-46 (18/092772, 679/092312), 37592-48 (679/052118, 679/092313), 37592-50 (679/092343), 37592-54 (679/072315), 37592-56 (18/721587), 37592-58 (679/092334), 37592-60 (679/042213, 679/072325, 679/092345), 37592-65 (679/072331), 37592-70 (679/042289, 679/072340, 679/092353), 37592-75 (18/429442, 679/092351), 37592-80 (679/052204, 679/072341, 679/092335), 37592-85 (679/042291, 679/072342, 679/092354), 37592-90 (679/042292, 679/092352). 6. Article Number (Lot Numbers): 31851-60 (18/373463, 18/813133), 31851-65 (18/374464), 31851-70 (18/375465), 31851-75 (18/376467), 31851-80 (18/125212, 18/377468, 18/431563, 18/867967), 31851-85 (18/044945, 18/378469, 18/441564), 31851-90 (18/045946, 18/343266, 18/451565), 31851-95 (18/046947, 18/128224, 18/379470, 18/461566), 31851-100 (18/129225, 18/471567, 18/821469, 18/860968), 31851-105 (18/380471), 31851-110 (18/901298, 18/387472), 31851-115 (18/381473, 18/048949), 31851-120 (18/049950, 18/133227, 18/511577, 18/862970), 31851-125 (18/050951, 18/347474, 18/521578), 31851-130 (18/051952, 18/344368, 18/531579), 31851-135 (18/382475, 18/541580), 31851-140 (18/052953, 18/551777, 18/863971), 31851-145 (18/054954, 18/137229, 18/345351, 18/561779), 31851-150 (18/138260, 18/191042, 18/346352, 18/571780, 18/797898), 31851-155 (18/201043, 18/384476), 31851-160 (18/062955, 18/799900, 18/866972), 31851-165 (18/063956, 18/211045, 18/385477), 31851-170 (18/141230, 18/221046, 18/348353), 31851-175 (18/064957, 18/142263, 18/386398), 31851-180 (18/065958, 18/143264, 18/388399), 31851-185 (18/389400), 31851-190 (18/066959, 18/390401), 31851-195 (18/067960, 18/391478), 31851-200 (18/013266, 18/392479), 31854-60 (18/393482), 31854-65 (18/394499, 18/691605), 31854-70 (18/070983, 18/395500), 31854-75 (18/071984, 18/396501), 31854-80 (18/072985, 18/397502, 18/731608, 18/871960), 31854-85 (18/149247, 18/240529, 18/741609, 18/872961), 31854-90 (18/150280, 18/398503, 18/751610, 18/873962), 31854-95 (18/399504, 18/761611, 18/874963), 31854-100 (18/400505, 18/771612, 18/868964), 31854-105 (18/401506), 31854-110 (18/073986, 18/869965), 31854-115 (18/074987, 18/402507, 18/801615), 31854-120 (18/403508, 18/870966), 31854-125 (18/404509, 18/821617), 31854-130 (18/075988, 18/405366, 18/831618), 31854-135 (18/076989, 18/406510), 31854-140 (18/407369, 18/851693), 31854-145 (18/408370, 18/861706), 31854-150 (18/160285, 18/409371, 18/871704), 31854-155 (18/410511), 31854-160 (18/1622951, 18/411372, 18/862761, 18/891708), 31854-165 (18/163286, 18/412512), 31854-170 (18/164296, 18/413513), 31854-175 (18/079992, 18/414514), 31854-180 (18/080993, 18/415515), 31854-185 (18/081994, 18/416373, 18/808929), 31854-190 (18/082995), 31854-195 (18/083996, 18/961715), 31854-200 (18/084997, 18/417516). 7. Article Number (Lot Numbers): 32351-10 (18/019937, 18/208200, 18/731287, 679/052205, 679/122249), 32351-12 (18/020938, 18/209211, 18/741316, 679/062203, 679/102243), 32351-14 (18/210212, 18/501230, 18/761312, 679/012324, 679/032524, 679/042419, 679/062225, 679/082501, 679/122207), 32351-16 (18/022940, 18/211212, 18/771313, 679/022311, 679/022533, 679/032525, 679/042421, 679/072201, 679/092501, 679/122204), 32351-18 (18/212213, 18/781322, 18/801041, 679/022312, 679/032526, 679/042427, 679/072202, 679/102501, 679/122208), 32351-20 (18/024942, 18/181975, 18/213214, 18/791323, 679/032527, 679/042428, 679/102502, 679/112225), 32351-22 (18/025943, 18/214215, 18/801324, 18/8013241, 18/821061, 679/052219, 679/112235), 32351-24 (18/026988, 18/215216, 18/811325, 18/8113251, 18/831062, 679/052206, 679/102239), 32351-26 (18/027989, 18/216217, 18/821326, 18/841063, 679/052202, 679/052407, 679/112236), 32351-28 (18/028990, 18/217218, 18/8313271, 679/052220, 679/102235), 32351-30 (18/029991, 18/218219, 18/841314, 679/062205, 679/122260), 32351-32 (18/219220, 18/301035, 18/851315, 18/8513151, 679/012303, 679/052203), 32351-34 (18/220221, 18/311041, 18/861328, 18/961089, 679/052243, 679/112229), 32351-36 (18/230222, 18/411090, 679/052221, 679/112241), 32351-38 (18/131369, 18/1313691, 18/221226, 18/321091, 26/F66144, 679/052207, 679/102247), 32351-40 (18/222223, 18/331092, 679/052208, 679/122243), 32351-42 (18/223224, 18/341093, 18/871329, 18/8713291, 679/112214), 32351-44 (18/351094, 18/881330, 18/8813301, 18/921138, 679/052209, 679/112211), 32351-46 (18/225227, 18/361095, 18/891331, 18/8913311, 18/931313, 679/042217, 679/112215), 32351-48 (18/226228, 18/371096, 679/052210, 679/122244), 32351-50 (18/227229, 18/381097, 18/941314, 679/012304, 679/052211), 32351-55 (18/391098, 18/901332, 18/951142, 18/951315, 679/042218, 679/112237), 32351-60 (18/229231, 18/401099, 18/961316, 679/042283, 679/122250), 32351-65 (18/981144, 679/022326, 679/042284), 32351-70 (18/236233), 32351-75 (18/237234, 679/022328), 32351-80 (18/461103, 679/042286), 32351-85 (18/431104), 32352-16 (679/022406, 679/072207, 679/122427), 32352-18 (679/012501, 679/022344, 679/052182), 32352-20 (18/670753, 679/012453, 679/012504, 679/022345, 679/052184, 679/052311), 32352-22 (18/237340, 679/012454, 679/022346, 679/022506, 679/062101, 679/072208, 679/122003), 32352-24 (18/238437, 18/672755, 679/022404, 679/032379, 679/032528, 679/052312, 679/062102, 679/072209, 679/122424), 32352-26 (18/239357, 18/673756, 679/022352, 679/022405, 679/032512, 679/052313, 679/072210, 679/122416), 32352-28 (18/240358, 18/674757, 679/022411, 679/032267, 679/032324, 679/032529, 679/052303, 679/072211, 679/122418), 32352-30 (18/675758, 18/950241, 679/022417, 679/022513, 679/032325, 679/052304, 679/072213, 679/102414, 679/102513), 32352-32 (18/242360, 18/676759, 679/022418, 679/032323, 679/032530, 679/052305, 679/072214, 679/122421), 32352-34 (18/243361, 18/677760, 679/022426, 679/022514, 679/032326, 679/052301, 679/072280, 679/102401), 32352-36 (18/244362, 18/678761, 679/032327, 679/032531, 679/042274, 679/052302, 679/072282, 679/122422), 32352-38 (18/245363, 18/679762, 679/022428, 679/0323112, 679/032392, 679/032513, 679/072283, 679/112502, 679/122413), 32352-40 (18/246364, 18/680763, 679/012506, 679/022438, 679/032268, 679/032375, 679/042342, 679/072112, 679/072285, 679/112505, 679/122419), 32352-42 (18/247365, 18/681764, 679/012507, 679/012508, 679/032347, 679/042343, 679/062246), 32352-44 (18/248366, 18/682765, 679/012217, 679/012503, 679/032339, 679/062247), 32352-46 (18/249367, 18/683766, 18/819818, 679/012218, 679/022526, 679/032371, 679/042332, 679/062249, 679/072294, 679/102402, 679/122501), 32352-48 (18/250368, 679/022444, 679/022505, 679/032372, 679/062251, 679/102180), 32352-50 (18/251369, 18/685768, 679/012509, 679/022452, 679/032364, 679/042329, 679/062253, 679/072295, 679/112434), 32352-55 (18/252370, 18/686769, 679/022504, 679/032376, 679/062255, 679/072296, 679/072297, 679/122401, 679/122504), 32352-60 (18/253438, 18/687770, 679/012222, 679/022527, 679/032328, 679/062257, 679/072298), 32352-65 (18/254460, 18/688798, 679/022457, 679/022520, 679/032343, 679/062259), 32352-70 (18/255371, 18/823821, 679/032344, 679/032408, 679/042316, 679/062261, 679/082201), 32352-75 (18/256429, 679/022522, 679/032398, 679/032399, 679/032409, 679/062263), 32352-80 (18/257430, 679/022523, 679/0323104, 679/0323107, 679/032410, 679/062265), 32352-85 (679/0323109, 679/0323113, 679/062267), 32352-90 (679/0323138, 679/0323141, 679/062268), 32352-95 (679/0323146, 679/0323148, 679/062271), 32352-100 (679/012230, 679/032266, 679/032411, 679/042301, 679/062273), 32352-105 (679/032412, 679/032509, 679/042311, 679/062275), 32352-110 (679/032413, 679/032521, 679/042312, 679/062277), 32352-115 (679/032418, 679/042319, 679/062279), 32352-120 (679/032419, 679/042320, 679/062281), 32455-18 (18/371232), 32455-20 (18/892124), 32455-22 (18/391234, 18/434375, 679/032395), 32455-24 (18/401235, 18/435376, 26/F62579, 679/032387, 679/032396, 679/092502), 32455-26 (18/411236, 18/436377, 679/032397, 679/092503), 32455-28 (18/437378, 679/032345), 32455-30 (18/256241, 679/032346, 679/032388), 32455-32 (18/438380, 18/441239, 26/F62581, 679/032384), 32455-34 (18/440381, 18/451240, 18/565613, 26/F62918, 679/032385), 32455-36 (18/441382, 18/461241, 26/F62582, 679/032389), 32455-38 (18/442383, 18/471242, 679/022353, 679/032363, 679/092507), 32455-40 (18/481243, 18/4812431, 26/F62583, 26F/62583, 679/022351, 679/032349), 32455-42 (18/491244, 26/F62584), 32455-44 (18/445386, 18/501245, 679/022354, 679/032366), 32455-46 (18/511246, 26/F62585, 679/032317, 679/032367), 32455-48 (18/231444, 18/446387, 679/022355, 679/032368), 32455-50 (18/531248), 32455-52 (18/541249, 679/032318, 679/032369), 32455-54 (18/377660, 18/392952, 18/551250), 32455-56 (679/032373), 32455-58 (18/378662, 18/412953, 18/571252), 32455-60 (679/032319, 679/032374), 32455-65 (18/591254), 32455-70 (18/601255, 26/F62586), 32455-75 (18/611256), 32455-80 (18/621257, 26/F62587), 32455-85 (18/231516, 26/F62588), 32455-90 (18/641259, 679/0323108), 32475-32 (26/F16726). 8. Article Number (Lot Numbers): 37455-18 (18/231558), 37455-20 (18/021319), 37455-22 (18/211320), 37455-24 (18/671425, 18/231558), 37455-26 (18/221322, 18/231449), 37455-28 (18/041323), 37455-30 (18/231324), 37455-32 (18/051325), 37455-34 (18/241326), 37455-36 (18/061375, 26/F62605), 37455-38 (18/251376), 37455-40 (18/532513, 18/691442, 26/F62606), 37455-42 (18/151343, 18/261380), 37455-44 (18/081388), 37455-46 (18/231515), 37455-48 (18/231514), 37455-50 (18/281394), 37455-52 (18/101395), 37455-54 (18/701444), 37455-56 (18/111408, 18/656368), 37455-60 (18/121449, 18/572515), 37455-65 (18/131479), 37455-70 (18/141480, 26/F62607), 37455-75 (18/151481, 26/F62608), 37455-80 (18/686476, 26/F62609), 37455-85 (18/171483, 26/F62610), 37455-90 (18/181484). 9. Article Number (Lot Numbers): 211911-4 (00/0825-10, 679/012425, 679/022531, 679/0323131, 679/062430, 679/0624301, 679/102431, 679/122267), 211911-5 (00/0724-28, 00/1225-04, 679/012426, 679/022321, 679/022518, 679/0323132, 679/052527, 679/0624311, 679/0624312, 679/102432), 211911-6 (00/1024-15, 679/012427, 679/022322, 679/022501, 679/042513, 679/062432, 679/0624322, 679/102433, 679/112177), 211911-7 (00/0724-31, 00/0724-32, 00/0724-33, 00/0724-34, 00/0724-35, 00/0725-16, 00/1225-05, 679/022323, 679/022502, 679/052529, 679/062231, 679/102434), 211911-8 (679/012428, 679/022503, 679/022532, 679/0323135, 679/112178, 679/112407), 211911-10 (00/0724-39, 00/1024-17, 679/0323127, 679/102429, 679/112179, 679/122266), 211911-12 (679/0323128, 679/102228, 679/112203, 679/112219), 211911-14 (679/0323129, 679/102229, 679/112221), 211911-16 (679/0323130, 679/062232, 679/112222), 211911-20 (679/062429, 679/112418, 679/122268). 10. Article Number (Lot Numbers): 212121-6 (679/052152, 679/062338, 679/122235). 11. Article Number (Lot Numbers): 212131-6 (679/062319, 679/122234). 12. Article Number (Lot Numbers): 212101-SM (679/042515, 679/052322, 679/122215, 679/122303, 679/122402). 13. Article Number (Lot Numbers): 212101-LA (00/0724-48, 00/1024-09, 679/062313, 679/062443, 679/112206, 679/122302, 679/122405). 14. Article Number (Lot Numbers): 212111-LA (679/032421, 679/042516, 679/062347, 679/062402, 679/062445, 679/122414), 212111-SM (00/0724-65, 00/1024-10, 00/1024-11, 679/022530, 679/032246, 679/062318, 679/062403, 679/062473, 679/092237, 679/112015, 679/122406). 15. Article Number (Lot Numbers): 212141-7 (00/0724-81, 00/0724-85, 679/032331, 679/052168, 679/062448, 679/122214), 212141-8 (679/022408, 679/032332, 679/052429, 679/062449, 679/0624491, 679/062474, 679/122233). 16. Article Number (Lot Numbers): 212151-7 (00/0624-06, 679/012449, 679/052153, 679/062219, 679/062450, 679/062475, 679/102230, 679/112239), 212151-8 (00/0624-11, 00/0724-51, 679/012450, 679/032248, 679/062451, 679/072508). 17. Article Number (Lot Numbers): 21194-6 (679/042247), 21194-7 (679/042249), 21194-8 (679/042250), 21195-10 (679/042252), 21195-12 (679/042253), 21195-7 (679/032221). 18. Article Number (Lot Numbers): 21208-13 (679/032414, 679/052428, 679/062122, 679/102435, 679/112162, 679/112174, 679/122221, 679/122222), 21209-13 (679/062442, 679/0624421, 679/112163, 679/112175, 679/112408, 679/122236). 19. Article Number (Lot Numbers): 21208-11 (679/012429, 679/062440, 679/0624401, 679/112160, 679/112172, 679/122219), 21209-11 (679/062441, 679/112161, 679/112173, 679/112412, 679/122237, 679/122238, 679/122239). 20. Article Number (Lot Numbers): 212061-10 (00/0724-110, 679/062311, 679/112217, 679/122218), 212061-14 (00/0724-42, 00/0724-47, 679/032238, 679/032337, 679/062312). 21. Article Number (Lot Numbers): 212071-10 (679/032415, 679/052329), 212071-14 (679/032338, 679/032416). 22. Article Number (Lot Numbers): 211751-5 (679/052320, 679/112180, 679/112202, 679/112220), 211771-4 (679/052321, 679/102227, 679/122301). 23. Article Number (Lot Numbers): 211821-10 (679/012423, 679/032333, 679/062426, 679/112176), 211821-11 (00/0724-71, 00/0724-74, 679/032334), 211821-12 (679/022320), 211821-14 (679/012424, 679/122217). 24. Article Number (Lot Numbers): 21161-4 (679/092320, 679/112201), 21161-6 (679/032305, 679/032306, 679/042304, 679/052506, 679/062218), 211621-4 (00/0724-18, 00/0724-63, 679/042305, 679/062423, 679/102226, 679/112414), 211621-6 (00/0825-13, 679/022529, 679/042306, 679/062424, 679/112415). 25. Article Number (Lot Numbers): 211631-6 (00/0125-35, 679/022515, 679/032315, 679/062302, 679/062425, 679/0624251, 679/112411), 211631-8 (00/0724-118, 00/1220-11, 679/062303, 679/122216).

Distribution pattern

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.