Lower risk Medical device recall · FDA · Published October 12, 2018

Zimmer Compress Devices: Update Needed for Surgical Technique

Zimmer Biomet recalls specific compress devices and instruments due to a correction in surgical technique instructions for anti-rotation pins. Affected items include various spindle and sleeve models.

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

🇺🇸 FDA recall #Z-0642-2019Medical device Zimmer Biomet ›

Lower-risk recall

Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.

Take action

Contact the company

Recalling firmZimmer Biomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989

✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling specific compress devices and instruments because surgical technique instructions were updated. This correction affects how anti-rotation pins are placed during procedures, but it does not pose a safety risk to users. Read more at govinfonow.com/recall/69638-zimmer-compress-devices-update-needed-for-surgical-technique.

Source Summary by GovInfoNow · govinfonow.com/recall/69638-zimmer-compress-devices-update-needed-for-surgical-technique · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0642-2019

Cite this page

“Zimmer Compress Devices: Update Needed for Surgical Technique.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69638-zimmer-compress-devices-update-needed-for-surgical-technique. Based on FDA recall #Z-0642-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0642-2019%22&limit=1).

The FDA announced on 2018-10-12 that Zimmer Biomet, Inc. is recalling Compress Devices and Instruments to update the surgical technique for selecting anti-rotation pin arrays. This Class II recall affects items distributed nationwide and in Canada, Argentina, Australia, Belgium, Chile, Finland, Japan, and the Netherlands.

How to tell if you have it

178350 Compress Device Anti-Rotation Spindle
178353 Compress Device Anti-Rotation Spindle
178356 Compress Device Anti-Rotation Spindle
178359 Compress Device Anti-Rotation Elliptical Spindle
178537 Compress Device Centering Sleeve 15mm
178541 Compress Device Centering Sleeve 19mm
178545 Compress Device Centering Sleeve 23mm
178544 Compress Device Centering Sleeve 22mm
178738 Compress Device Centering Sleeve 28mm
178542 Compress Device Centering Sleeve 20mm
32-481123 Compress Instrument Drill For Anti-Rotation Pin
178757 Mini Taper Spindle, 400 lbs, Extra Small
178758 Mini Taper Spindle, 600 lbs, Extra Small
178759 Mini Taper Spindle, 800 lbs, Extra Small
178787 Short Mini Taper Spindle, 400 lbs, Extra Small
178788 Short Mini Taper Spindle, 600 lbs, Extra Small
178789 Short Mini Taper Spindle, 800 lbs, Extra Small

The hazard

The recall corrects the surgical technique for the Compress System to make users aware of changes made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.

Context

GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since 2017-06-05. Other recent recalls include the 2020-11-20 Zimmer Biomet Spinal Rod Cutter Recall for fracture risk, the 2020-11-17 Polaris 5.5 Spinal System Recall for spinal screw failure risk, and the 2020-09-24 Hip Cup Recall for sterilant biocompatibility concerns. Similar recent recalls of similar products include the 2026-05-20 Zimmer Off-Axis Shoulder System Recalled Due to Plastic Guide Breakage and the 2026-05-20 Zimmer Off-Axis Shoulder System Guide Recall for plastic guides that may break during use.

How to tell if you have this one

Check if your device has item numbers like 178350, 178353, 178356, or other listed models from the recall notice. These items are used in surgical procedures and include specific spindle and sleeve components.

Brand
Zimmer Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Review Instructions
Check the surgical technique instructions for the placement of anti-rotation pins to ensure you are using the updated selection criteria.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign: CANADA ARGENTINA AUSTRALIA BELGIUM CHILE FINLAND JAPAN NETHERLANDS” 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 18 months after the firm started it.

Oct 12, 2018Firm started the recall
Dec 19, 2018FDA classified it Class II
Dec 26, 2018Published in FDA’s Enforcement Report
Apr 17, 2020FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What item numbers are affected?

Affected item numbers include 178350, 178353, 178356, 178537, 178541, 178545, 178544, 178738, 178542, 32-481123, 178757, 178758, 178759, 178787, 178788, and 178789.

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Link to this recall

<a href="https://govinfonow.com/recall/69638-zimmer-compress-devices-update-needed-for-surgical-technique">Zimmer Compress Devices: Update Needed for Surgical Technique (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-0642-2019 (October 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0642-2019 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.