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High RiskFDAfda-Z-1241-2018OTHER

AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical ...

Units Affected
387
Recall Date
January 30, 2018
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1241-2018.

Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1241-2018.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Encore Medical, Lp or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1241-2018.

Encore Medical, Lp

FDA

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Encore Medical, Lp Recall FAQ

Encore Medical, Lp is the subject of a medical implants safety report: AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical .... The notice was published on January 30, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 387 units are potentially affected.