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Terminated

Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

FDA Recall Z-1239-2018 · Posted 2018-03-14

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeJDC
Date Initiated2018-01-24
Date Terminated2019-04-09
Product Quantity9

Reason for Recall

One lot of humeral stem implants do not include the humeral bushing components.

Firm Action

1. Immediately locate and quarantine affected product in your inventory. 2. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to [email protected] within three (3) days. b. Request a Return Authorization Number. Mark RECALL on the outside of the returned cartons.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed in China and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001989COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIESZimmer, Inc. · 2000-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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