Stryker GmbH: 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.

Recall number

Z-2382-2020

Recalling firm

Stryker GmbH

Product

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.

Status

Terminated

Initiated

2020-05-07

Posted

2020-06-16

Terminated

2023-09-21

Reason

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

Root cause

Process control

Action

Stryker issued Urgent Medical Device Recall (UMDR) - PFA 2365134 letter on May 7, 2020 to affected US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. An OUS customer letter will also be issued at the country level The letter states reason for recall, heath risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list is at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Under 21 CFR 803, manufactures are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing soprodexpreports@stryker.com. 5. A response is required, even though you may not have any physical inventory on site anymore. 6. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-912-8457 or email to StrykerOrtho8810@Stericycle.com. 7. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 8.Branches/Agencies Only: Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East Mahwah, NJ 07430 Ref. PFA 2365134 Questions or concerns after reviewing the letter, please contact Customer Service at (201) 831-5000.

Quantity

OUS: 1404

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.

Lot, serial or model codes

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

510(k) numbers

["K032244"]

PMA numbers

not on file

Product code

HSB

Firm FEI

3002807830

Firm city

Selzach

Firm state

not on file

Firm country

Switzerland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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