Z-0590-2019Class II
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Zimmer GmbH / initiated 2018-10-10 / Terminated / root cause: labeling and UDI
Zimmer Biomet, Inc. began a recall of Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 on . FDA classified it as Class II and gives the reason as "Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0590-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
- Product code
- KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Reason for recall
- Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
- Root cause tag
- labeling and UDI
- FDA root cause
- Under Investigation by firm
- Action
- On October 10, 2018, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were advised of the product issue. Distributors were asked to take the following actions: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. If the affected product is located at a hospital, remove the product from the hospital and provide the Risk Manager Recall Notice to the hospital and request that they sign the Certificate of Acknowledgement. 4. Immediately return all affected product from your distributorship and from affected hospitals within your territory along with hospital Certificate of Acknowledgement. a. For each return, complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 5. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals included with the email notification sent to your facility. b. Identify whether there are any additional hospitals that Zimmer Biomet is not aware of and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. Hospital Risk Managers were asked to take the following actions: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your
- Quantity in commerce
- 3 total
- Distribution
- Distributed to accounts in IN, MD, MO, MS, and NM.
- Product codes and lots
- 068390
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0590-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0591-2019 | Class II | Terminated | Voluntary: Firm initiated |
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