Z-0300-2020Class II
Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460...
Zimmer GmbH / initiated 2019-10-10 / Terminated / root cause: packaging
Zimmer Biomet, Inc. began a recall of Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520... on . FDA classified it as Class II and gives the reason as "Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration)". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0300-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525
- Product code
- PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- Reason for recall
- Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Root cause tag
- packaging
- FDA root cause
- Packaging change control
- Action
- The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time. 3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected. 4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components. 5. Complete the Certificate of Acknowledgement and return to the firm. 6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation. If you have further questions or concerns regarding this recall, please call the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
- Quantity in commerce
- 5,459,583 total devices
- Distribution
- Distributed nationwide.
- Product codes and lots
- All product manufactured prior to January 2014.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0298-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0299-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0300-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0301-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0302-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0303-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0304-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0305-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0306-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0307-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0308-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0309-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0310-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0311-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0312-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0313-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0314-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0315-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0316-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0317-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0318-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0319-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0320-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0321-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0322-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0323-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0324-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0325-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0326-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0327-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0328-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0329-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0330-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0331-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0332-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0333-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0334-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0335-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0336-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0337-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0338-2020 | Class II | Terminated | Voluntary: Firm initiated |
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