Coonrad/Morrey Elbow Implant System humeral assembly 4IN… recallZ-1239-2018 · Zimmer Biomet, Inc. · initiated Jan 24, 2018
Class II Terminated All recalls posted in March 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One lot of humeral stem implants do not include the humeral bushing components.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1239-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 24, 2018
- Posted by the FDA
- Mar 14, 2018
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 9
- Product code
- JDC
- FDA submissions
- K001989
- Distribution
- Distributed in China and Taiwan.
Product description
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Code information (models, lots, serial numbers)
Lot Number: 63694912
Other devices under the same FDA submission
13 devices cleared under K001989 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 32-8105-27-04Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED9 reports
- NA 32-8105-25-04Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED9 reports
- NA 32-8105-27-01Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED6 reports
- NA 32-8105-35-06Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED4 reports
- NA 32-8105-27-06Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- NA 32-8105-53-02Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- NA 32-8105-25-01Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- NA 32-8105-25-06Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- NA 32-8105-25-08Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- NA 32-8105-27-01Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- NA 32-8105-93-02Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- NA 32-8105-73-01Zimmer, Inc. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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