Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SCP PLT 135DX8H TUBE&SCP PLT 135D
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is recalling approximately 972,125 units of sterile-packaged trauma tubes and plates across six different package configurations that were distributed worldwide. The recall was initiated because multiple test samples from each configuration failed simulated distribution and shipping tests, resulting in breaches of inner or outer package trays or loss of seal integrity.
The affected devices are identified by specific item numbers and have expiration dates prior to July 2024. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
Reason for recall: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. Distribution: Worldwide Distribution. Quantity: 972,125 units Lot/code info: Item Numbers: 00118109006, 00118109008, 00118109010, 00118109506, 00118109508, 00118109510, 00118113008, 00118113010, 00118113012, 00118113014, 00118113508, 00118113510, 00118113512, 00118113514, 00118114008, 00118114010, 00118114012, 00118114014, 00118114508, 00118114510, 00118114512, 00118114514, 00118115006, 00118115008, 00118115010, 00118115012, 00118115014, 00119309006, 00119309008, 00119309010, 00119309012, 00119309014, 00119309506, 00119309508, 00119309510, 00119309512, 00119309514, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514, 00119313008, 00119313010, 00119313012, 00119313014, 00119313508, 00119313510, 00119313512, 00119313514, 00119314008, 00119314010, 00119314012, 00119314014, 00119314508, 00119314510, 00119314512, 00119314514, 00119315008, 00119315010, 00119315012, 00119315014, 00119413008, 00119413508, 00119414008, 00119414508, 00119415008, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514 EXPIRATION DATE PRIOR TO 2024-07
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.