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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85681

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

Open FDA event record

Event summary

Timeline bucket
May 07, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker 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

15 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 15

Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2373-2020
Recall number
Z-2373-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
56 OUS

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K0386FB

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 2 of 15

Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2374-2020
Recall number
Z-2374-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
26 OUS

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K020791

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 3 of 15

Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2375-2020
Recall number
Z-2375-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
186 OUS

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K020795, K020796

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 4 of 15

Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2376-2020
Recall number
Z-2376-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
109 OUS

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K020793, K020794

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 5 of 15

Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2377-2020
Recall number
Z-2377-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
69 OUS

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K02803B

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 6 of 15

Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2378-2020
Recall number
Z-2378-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
US 3; OUS 2

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K037E2D

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 7 of 15

Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2379-2020
Recall number
Z-2379-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
US 3; OUS 13

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K01CF9F

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 8 of 15

Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2380-2020
Recall number
Z-2380-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
OUS 40

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K0207C2

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 9 of 15

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2381-2020
Recall number
Z-2381-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
US 46; OUS 314

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K0207B0, K02C1A8, K02C1A9, K0302E4

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 10 of 15

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2382-2020
Recall number
Z-2382-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
OUS: 1404

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K02AE3F, K02C191, K02C1AA, K0302F9, K0302FA, K0302FD, K030307, K030313, K030315, K030EE3, K030EE4, K030EE5, K030EE8, K031B63, K032879, K0E902D, K0E9086, K0E90B7, K0E90BB, K0EAC03

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 11 of 15

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2383-2020
Recall number
Z-2383-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
US 76; OUS 290

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K029C38, K029C39, K030EF6, K030EF7, K030EF9, K031B66

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 12 of 15

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2384-2020
Recall number
Z-2384-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
OUS 400

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K0207B3, K031B6B, K031B6C, K033439

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 13 of 15

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2385-2020
Recall number
Z-2385-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
US:127; OUS 454

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K02C1BB, K03033E, K030342, K03035D, K030F17, K030F1D, K031B6E, K031B70, K0328A5

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 14 of 15

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2386-2020
Recall number
Z-2386-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
OUS 121

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K030F1E, K033442

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

device · product 15 of 15

Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Z-2387-2020
Recall number
Z-2387-2020
Initiated
May 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
US 3; OUS 1

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Code information

Lot Number: K03A7FF

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.