Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)
FDA device recall Z-1239-2018 · posted 2018-03-14 · Terminated
Recall details
- Recalling firm
- Zimmer Biomet, Inc.
- Reason for recall
- One lot of humeral stem implants do not include the humeral bushing components.
- Action taken
- 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 CorporateQuality.PostMarket@zimmerbiomet.com 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
- Status
- Terminated
- Product code
- JDC
- Quantity affected
- 9
- Distribution
- Distributed in China and Taiwan.
- Date initiated
- 2018-01-24
- Date posted
- 2018-03-14
- Date terminated
- 2019-04-09
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES (K001989) | Zimmer, Inc. | 2000-07-25 |