Z-0299-2020Class II
Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813...
Zimmer GmbH / initiated 2019-10-10 / Terminated / root cause: packaging
Zimmer Biomet, Inc. began a recall of Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113... 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-0299-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 00434211813 00434810613 00434810813 00434810817 00434810913 00434811013 00434811017 00434811113 00434811213 00434811217 00434811313 00434811413 00434811417 00434811513 00434811613 00434811713 00434811813 00434900813 00434900817 00434901013 00434901017 00434901213 00434901217 00434901413 00434903700 00434903811 00434903909 00434903912 32855090339 32855090353 32855090368 32855090375 32855090395 32855090512 32855090519 32855090520 32855090531 32855090585 32855090593 32855090598 32855090599 32855090628 32855090636 32855090637 32855090640 32855090658 32855090659 32855090734 47430703100 47430704100 47430706100
- Product code
- KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- 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 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.