Use caution Medical device recall · FDA · Published June 27, 2019

Medicrea Pass LP Screws: Risk of Postoperative Pain from Too-Long Screws

Medicrea recalls Pass LP screws (7.5mm x 45mm) that may be too long, causing postoperative pain. Affected units have specific lot numbers and expiration dates.

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

🇺🇸 FDA recall #Z-0753-2020Medical device Medicrea ›

Use caution until it’s fixed

It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain.

Take action

Contact the company

Recalling firmMedicrea International5389 Route De Strasbourg, Vancia · Rillieux La Pape, France

✎ GovInfoNow plain-language explainer

Medicrea is recalling Pass LP screws that could be too long (50mm instead of 45mm), risking nerve contact and postoperative pain after spinal surgery. This affects patients who received these screws during spinal procedures. Read more at govinfonow.com/recall/67555-medicrea-pass-lp-screws-risk-of-postoperative-pain-from-too.

Source Summary by GovInfoNow · govinfonow.com/recall/67555-medicrea-pass-lp-screws-risk-of-postoperative-pain-from-too · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0753-2020

Cite this page

“Medicrea Pass LP Screws: Risk of Postoperative Pain from Too-Long Screws.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67555-medicrea-pass-lp-screws-risk-of-postoperative-pain-from-too. Based on FDA recall #Z-0753-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0753-2020%22&limit=1).

The FDA announced on June 27, 2019, that Medicrea International is recalling Medicrea Pass LP polyaxial pedicle screws due to a length discrepancy. Some 45mm screws are actually 50mm long, which could cause postoperative pain by contacting nerves. Owners should contact the company for a remedy.

How to tell if you have it

Medicrea Pass LP
REF B02217545
Non Sterile
Material: Ti-6Al-4V ELI
VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM
POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM
Lot #/Expiration Date: 19A0630/January 03, 2029
19B0329 /January 21th, 2029
19C0734 /March 03, 2029
UPC: 03613720177906

The hazard

Some Pedicle system screws identified as 45mm long have an actual length of 50mm. Because pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area, a screw that is too long could come into contact with the nerves and cause postoperative pain.

Context

GovInfoNow's records show Medicrea International has 8 other recalls on record since September 16, 2019. Recent Medicrea recalls include an October 29, 2025 recall of IB3D PL Instruments Set for a handle that may untread from the shaft and a December 3, 2024 recall of UNiD Spine Analyzer Software for incorrect surgical calculations. Other recent recalls of similar products include XTANT Medical Xpress Pedicle Screw System (February 18, 2026), Innovasis Anti-Torque Vector Pedicle Screw LS-749 (May 22, 2026), and Tornier Perip Screw (December 19, 2025).

How to tell if you have this one

Check for the model 'Pass LP' with dimensions 7.5mm x 45mm. Affected units have lot numbers 19A0630 (exp. Jan 2029), 19B0329 (exp. Jan 2029), or 19C0734 (exp. Mar 2029).

Brand
Medicrea
Product
Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the screw model and lot number to confirm if it's affected.
Contact Healthcare Provider
Inform your surgeon about the recall and discuss potential risks if you received the recalled screws.

Where it went and when

Where it was distributed

Distributed in 7 states, and outside the U.S.

FDA distribution: “US: NY, CO, OH, AZ, FL, TX, PA OUS: France, Belgium, South Africa, China, Spain, Portugal” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Colorado, Florida, New York, Ohio, Pennsylvania, Texas.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Jun 27, 2019Firm started the recall
Dec 30, 2019FDA classified it Class II
Jan 8, 2020Published in FDA’s Enforcement Report
Nov 19, 2020FDA 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/67555-medicrea-pass-lp-screws-risk-of-postoperative-pain-from-too">Medicrea Pass LP Screws: Risk of Postoperative Pain from Too-Long Screws (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-0753-2020 (June 27, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0753-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.