Z-1053-2018Class II
ZIMMER PATELLA FEMORAL JOINT Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe...
Zimmer GmbH / initiated 2017-11-29 / Terminated / root cause: packaging
Zimmer Biomet, Inc. began a recall of ZIMMER PATELLA FEMORAL JOINT Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint on . FDA classified it as Class II and gives the reason as "The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1053-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- ZIMMER PATELLA FEMORAL JOINT Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
- Product code
- KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- Reason for recall
- The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag. A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action: Risk Manager Responsibilities: 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 Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Distributor Responsibilities: 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. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. 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. 4. Return the Additi
- Quantity in commerce
- 13,227 in total
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
- Product codes and lots
- 00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1014-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1015-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1016-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1017-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1018-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1019-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1020-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1021-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1022-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1023-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1024-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1025-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1026-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1027-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1028-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1029-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1030-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1031-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1032-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1033-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1034-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1035-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1036-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1037-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1038-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1039-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1040-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1041-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1042-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1043-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1044-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1045-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1046-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1047-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1048-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1049-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1050-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1051-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1052-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1053-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1054-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1055-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1056-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1057-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1058-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1059-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1060-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1061-2018 | Class II | Terminated | Voluntary: Firm initiated |
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