Stop using now Medical device recall · FDA · Published May 7, 2020

Stryker Compression Screw Recall: Blister Pack Sterility Risk

Stryker recalls Advanced T2 Tibia Compression Screws (Catalog 18220001S) due to potential blister pack compromise affecting sterility. This single-use medical implant may not be sterile if the packaging is damaged.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2374-2020Medical device Stryker ›

Stop using this now

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

Take action

Contact the company

Recalling firmStryker GmbHBohnackerweg 1 · Selzach, Switzerland

✎ GovInfoNow plain-language explainer

Stryker is recalling a specific type of bone fixation screw because the blister pack might be damaged, which could mean the screw isn't sterile when used. This is a serious risk for patients undergoing surgery since medical implants must be sterile. Read more at govinfonow.com/recall/65202-stryker-compression-screw-recall-blister-pack-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65202-stryker-compression-screw-recall-blister-pack-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2374-2020

Cite this page

“Stryker Compression Screw Recall: Blister Pack Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65202-stryker-compression-screw-recall-blister-pack-sterility-risk. Based on FDA recall #Z-2374-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2374-2020%22&limit=1).

The FDA announced on May 7, 2020, that Stryker GmbH is recalling the Stryker Compression Screw, Advanced T2 Tibia (Catalog Number: 18220001S) due to potential compromised blister pack seal integrity. The agency stated sterility cannot be assured for these single-use implants.

How to tell if you have it

Brand: Stryker
Product: Stryker Compression Screw, Advanced T2 Tibia
Catalog Number: 18220001S
Lot Number: K020791

The hazard

The FDA said the seal integrity of the blister pack may be compromised, meaning sterility cannot be assured for the Stryker Compression Screw, Advanced T2 Tibia.

Context

GovInfoNow's records show Stryker GmbH has issued 20 other recalls since March 12, 2018. Recent brand recalls include the Stryker Hoffmann II Connecting Rod Micro 3 x 60mm (July 1, 2026) and the Stryker Gamma4 Right Long Nail (May 28, 2025). Other recent recalls of similar products include the Stryker BARD Dynamic Tip Steerable (April 10, 2026) and Medline Surgical Packs (Jan. 7, 2026).

How to tell if you have this one

Check for the catalog number 18220001S on the blister pack. This product was sold with lot number K020791 and is used for temporary bone fixation.

Brand
Stryker
Category
Medical device

FDA recall event · 15 products

All 15 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
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.

Recall number	Product, codes & lots	Quantity
Z-2373-2020	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.; Lot Number: K0386FB	56 OUS
Z-2374-2020	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.; Lot Number: K020791	26 OUS
Z-2375-2020	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.; Lot Number: K020795, K020796	186 OUS
Z-2376-2020	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.; Lot Number: K020793, K020794	109 OUS
Z-2377-2020	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.; Lot Number: K02803B	69 OUS
Z-2378-2020	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.; Lot Number: K037E2D	US 3; OUS 2
Z-2379-2020	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.; Lot Number: K01CF9F	US 3; OUS 13
Z-2380-2020	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.; Lot Number: K0207C2	OUS 40
Z-2381-2020	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.; Lot Number: K0207B0, K02C1A8, K02C1A9, K0302E4	US 46; OUS 314
Z-2382-2020	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.; Lot Number: K02AE3F, K02C191, K02C1AA, K0302F9, K0302FA, K0302FD, K030307, K030313, K030315, K030EE3, K030EE4, K030EE5, K030EE8, K031B63, K032879, K0E902D, K0E9086, K0E90B7, K0E90BB, K0EAC03	OUS: 1404
Z-2383-2020	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.; Lot Number: K029C38, K029C39, K030EF6, K030EF7, K030EF9, K031B66	US 76; OUS 290
Z-2384-2020	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.; Lot Number: K0207B3, K031B6B, K031B6C, K033439	OUS 400
Z-2385-2020	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.; Lot Number: K02C1BB, K03033E, K030342, K03035D, K030F17, K030F1D, K031B6E, K031B70, K0328A5	US:127; OUS 454
Z-2386-2020	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.; Lot Number: K030F1E, K033442	OUS 121
Z-2387-2020	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.; Lot Number: K03A7FF	US 3; OUS 1

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately discard the screw if you have it, as it may not be sterile.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “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:…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

May 7, 2020Firm started the recall
Jun 16, 2020FDA classified it Class II
Jun 24, 2020Published in FDA’s Enforcement Report
Sep 21, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/65202-stryker-compression-screw-recall-blister-pack-sterility-risk">Stryker Compression Screw Recall: Blister Pack Sterility Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2374-2020 (May 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2374-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.